Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Skin stapler/staple, non-bioabsorbable FDA UDI
- Device Name
- Proximate Plus MD Multi-Directional Release Skin Staplers contains 35 Stainless Steel Staples approximate Closed Dimensions: 5.7mm x 3.9mm Regular FDA UDI
- Model / Reference
- PMR35 EUDAMEDFDA UDI
- Description
- Proximate Plus MD Multi-Directional Release Skin Staplers contains 35 Stainless Steel Staples approximate Closed Dimensions: 5.7mm x 3.9mm Regular FDA UDI
Identifiers
- Catalog Number
- PMR35 FDA UDI
- Primary DI / UDI-DI
- D-USMF000013107000068MV EUDAMED10705036002635 FDA UDI
- Basic UDI-DI
- B-USMF000013107000068MV EUDAMED
- FDA Product Code
- GDT FDA UDI
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE EUDAMED
- GMDN Term
- Skin stapler/staple, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4760 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Proximate by Ethicon Endo-Surgery, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000013107000068MV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Ethicon Endo-Surgery (Europe) GmbH DE-AR-000012751
Sources (2)
- EUDAMED 4b7b984c-fa44-4de4-9d9c-e240bfb9fef8 61 fields · synced Jul 14, 2026
- FDA UDI a2f07232-10e0-4388-9520-551713527a3c 35 fields · synced May 30, 2026