Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Skin stapler/staple, non-bioabsorbable FDA UDI
- Device Name
- ETHICON PROXIMATE Rotating Head Skin Staplers EUDAMEDProximate RH Rotating Head skin Staplers (35 Wide) Contains 35 Stainless Steel Staples FDA UDI
- Model / Reference
- PRW35 EUDAMEDFDA UDI
- Description
- Proximate RH Rotating Head skin Staplers (35 Wide) Contains 35 Stainless Steel Staples FDA UDI
Identifiers
- Catalog Number
- PRW35 FDA UDI
- Primary DI / UDI-DI
- 10705036013020 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000026A 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
Yes
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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000026A | 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
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 0de488d4-a144-49e2-bd28-ed26c7cdb411 61 fields · synced Jun 9, 2026
- FDA UDI 3574ce3c-a84b-421e-ab61-d448cd5b4cbe 35 fields · synced May 27, 2026