Schedule 5 Appendix c other Medical Devices




НазваниеSchedule 5 Appendix c other Medical Devices
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Billing Code Product Name Further Description Size Notations

AS016 GIA*, ILA* Reloading Unit Titanium. Multifire 60 Cartridge, 90mm (3.8, 4.8mm) Temporary Approval

Inverted Linear Anastomosis

Cartridges 3944, 3943, 3978, 3946,

3945, 3976, 3977

AS017 GIA*, ILA* Reloading Unit Titanium. Multifire 60 Cartridge, 100mm (3.8,4.8mm) Temporary Approval

Inverted Linear Anastomosis

Cartridges 3944, 3943, 3978, 3946,

3945, 3976, 3977

AS018 TA*, Stapler Premium Multifire TA* Disposable 30mm (2.5, 3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS019 PI*, Stapler Premium Multifire TA* Disposable 30mm (2.5, 3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS020 TA*, Stapler Premium Multifire TA* Disposable 55mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS021 TA*, Stapler Premium Multifire TA* Disposable 60mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS022 PI*, Stapler Premium Multifire TA* Disposable 55mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS023 TA*, Stapler Premium Multifire TA* Disposable 90mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS024 PI*, Stapler Premium Multifire TA* Disposable 90mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS025 TA*, Reloading Units Premium Multifire TA* Disposable 30mm (2.5, 3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS026 PI*, Reloading Unit Premium Multifire TA* Disposable 30mm (2.5, 3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

AS027 TA*, Reloading Units Premium Multifire TA* Disposable 55mm (3.5, 4.8mm) Temporary Approval Surgical Stapler and Loading Unit

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Billing Code Product Name

Further Description

Size

Notations

AS028

TA*, Reloading Units

Premium Multifire TA* Disposable

60mm (3.5, 4.8mm)

Temporary Approval




Surgical Stapler and Loading Unit







AS029

PI*, Reloading Units

Premium Multifire TA* Disposable

55mm (3.5, 4.8mm)

Temporary Approval




Surgical Stapler and Loading Unit







AS030

TA* Reloading Units

Premium Multifire TA* Disposable

90mm (3.5mm, 4.8mm)

Temporary Approval




Surgical Stapler and Loading Unit







AS031

PI* Reloading Units

Premium Multifire TA* Disposable

90mm (3.5, 4.8mm)

Temporary Approval




Surgical Stapler and Loading Unit







AS032

Poly CS

Premium 57 Disposable Surgical

One size only

Temporary Approval




Stapler







AS033

Power Stapler and Staples (Powered

LDS Instrument & Cartridges

One size only

Temporary Approval




LDS*)

(Disposable Loading Unit)







AS034

LDS* Reloading Unit

LDS Instrument & Cartridges

One size only

Temporary Approval




(Disposable Loading Unit)







AS035

Roticulator*

Roticulator 30

30mm (3.5, 4.8mm)

Temporary Approval

AS036

Roticulator*

Roticulator 55

55mm (3.5, 4.8mm)

Temporary Approval

AS037

ROTICULATOR*

Polysorb 55 Disposable Loading

55mm (3.5, 4.8mm)

Temporary Approval

AS046

Endo GIA* Universal Stapling

Multifire 30 disposable stapler

12mm

Temporary Approval




with titanium staples







AS047

Endo GIA* II

Multifire 30 disposable stapler

12mm

Temporary Approval




with titanium staples







AS048

Versafire GIA*

Disposable surgical stapling

One size only

Temporary Approval




instruments or cartridges







AS066

Surgiclip RLT Manual Clip System

Titanium

Small, Med/Large, Medium,

Temporary Approval







Large




AS067

Surgiclip RLT Disposable Loading

Titanium

6,12,18,24 clips

Temporary Approval

AS070

ENDO UNIVERSAL*

Titanium Surgical Stapler

4mm, 4.8mm (10 staples)

Temporary Approval




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Billing Code Product Name Further Description Size Notations

AS072 PPCEEA* Titanium Surgical Stapler AS075 ENDO TA* Titanium Surgical Stapler AS076 ENDO TA* reloading unit Titanium Surgical Stapler DLU AS077 ENDO GIA* Titanium Surgical Stapler AS078 ENDO GIA* Titanium Surgical Stapler AS079 ENDO GIA* Titanium Surgical Stapler AS080 ENDO GIA* reloading unit Titanium Surgical Stapler DLU AS081 ENDO GIA* reloading unit Titanium Surgical Stapler DLU AS082 ENDO GIA* reloading unit Titanium Surgical Stapler DLU AS091 VERSA TACK* stapler Titanium Surgical Stapler AS092 VERSA TACK* reloading unit Titanium Surgical Stapler DLU AS094 GIA*, ILA* Staplers Titanium 21, 25, 28, 31, 34mm Temporary Approval 30mm Temporary Approval 30mm -2.5, 30mm-3.5 Temporary Approval 30 - 35mm Temporary Approval 45mm Temporary Approval 60mm Temporary Approval 30 - 35mm Temporary Approval 45mm Temporary Approval 60mm Temporary Approval 4, 4.8mm (10 staples) Temporary Approval 4mm, 4.8mm (10 staples) Temporary Approval 80mm (3.8mm, 4.8mm) Temporary Approval. * Trademark

of United States Surgical

AS102 DST Series* Linear Staplers Titanium staples used for DST TA90-3.5; DST TA90-4.8 Temporary approval hemostatic closure of specific organs and blod vessels (ex bowel,

AS103 DST Series* Linear Stapler Titanium staples used for DST TA90-3.5 DLU; DST Temporary approval Disposable Loading Units hemostatic closure of specific TA90-4.8 DLU organs and blod vessels (ex bowel,

AS104 DST Series* Linear Staplers Titanium staples used for DST TA45-3.5; DST TA45-4.8 Temporary approval hemostatic closure of specific organs and blod vessels (ex bowel,

AS105 DST Series* Linear Staplers Titanium staples used for DST TA60-3.5; DST TA60-4.8 Temporary approval hemostatic closure of specific organs and blod vessels (ex bowel,

Page 10 of 68


Billing Code Product Name Further Description Size Notations

AS106 DST Series* Linear Stapler Titanium staples used for DST TA45-3.5 DLU; DST Temporary approval Disposable Loading Units hemostatic closure of specific TA45-4.8 DLU organs and blod vessels (ex bowel,

AS107 DST Series* Linear Stapler Titanium staples used for DST TA60-3.5 DLU; DST Temporary approval Disposable Loading Units hemostatic closure of specific TA60-4.8 DLU organs and blod vessels (ex bowel,

AS108 DST Series* Linear Staplers Titanium staples used for DST TA30-3.5; DST Temporary approval hemostatic closure of specific TA30-4.8; DST TA30V3 organs and blod vessels (ex bowel,

AS109 DST Series* Linear Stapler Titanium staples used for DST TA30-3.5 DLU; DST Temporary approval Disposable Loading Units hemostatic closure of specific TA30-4.8 DLU; DST TA30V3 organs and blod vessels (ex bowel, DLU




Surgical Packs

AS069 ENDO - HERNA* Titanium Surgical Stapler 4mm, 4.8mm (10 staples) Temporary Approval

AS071 ENDO - Herna reloading unit Titanium Surgical Stapler DLU 4, 4.8mm (10 staples) Temporary Approval



Unknown / Unassigned

AS038 STAT TACK* and Endoscopic Tacker Endoscopic TACKER*, used with 20 tacks Temporary Approval Device multi use handle

AS039 STAT TACK* and Endoscopic Tacker Endoscopic TACKER* 20 tacks Temporary Approval Device

AS040 STAT TACK* and Endoscopic Tacker Endoscopic TACKER* 30 tacks Temporary Approval Device

AS095 STAT TACK* and Endoscopic Tacker STAT TACK* One size only Temporary Approval Device

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