Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Open-surgery manual linear cutting stapler, single-use FDA UDI
- Device Name
- PROXIMATE Reloadable Linear Cutter with Safety Lock-out EUDAMEDProximate Reloadable Linear Cutter With Safety Lock-out. 75mm linear cutter. FDA UDI
- Model / Reference
- TCT75 EUDAMEDFDA UDI
- Description
- Proximate Reloadable Linear Cutter With Safety Lock-out. 75mm linear cutter. FDA UDI
Identifiers
- Catalog Number
- TCT75 FDA UDI
- Primary DI / UDI-DI
- 10705036013150 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000476Y EUDAMED
- FDA Product Code
- GDW FDA UDI
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
- GMDN Term
- Open-surgery manual linear cutting stapler, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4750 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery manual linear cutting stapler, single-use
Proximate by Ethicon Endo-Surgery, LLC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000476Y | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 301a662a-e3f6-4423-be62-7e7273a733ed 61 fields · synced Jul 11, 2026
- FDA UDI 2d0ebe02-5e34-47d0-be0b-c5554fcb5e45 35 fields · synced May 30, 2026