Identity
- Trade Name
- PROXIMATE EUDAMEDFDA UDI
- Generic Name
- Skin staple remover, single-use FDA UDI
- Device Name
- ETHICON PROXIMATE Skin Stapler Extractor EUDAMEDProximate Skin Staple Extractors FDA UDI
- Model / Reference
- PSX EUDAMEDFDA UDI
- Description
- Proximate Skin Staple Extractors FDA UDI
Identifiers
- Catalog Number
- PSX FDA UDI
- Primary DI / UDI-DI
- 10705036013037 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a0000168 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- H02010106 METAL SURGICAL STAPLE REMOVERS, SINGLE-USE EUDAMED
- GMDN Term
- Skin staple remover, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 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
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 | 0705036a0000168 | 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 d490603a-334d-4dbe-8aeb-ec8d7a821c28 61 fields · synced Jun 9, 2026
- FDA UDI bcd9ca81-9250-4ce8-926c-1b913f2a0864 35 fields · synced May 30, 2026