Identity
- Trade Name
- WECK FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- WECK ENDO FASCIAL CLOSURE SYSTEM FDA UDI
- Model / Reference
- IPN002709 FDA UDI
- Description
- WECK ENDO FASCIAL CLOSURE SYSTEM FDA UDI
Identifiers
- Catalog Number
- EFX001 FDA UDI
- Primary DI / UDI-DI
- 04026704558834 FDA UDI
- 510(k) Number
- K103412 FDA UDI
- FDA Product Code
- OCW FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10.25 Inch FDA UDI
Category: Suturing unit, single-use
Weck by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI add87a6f-4337-4352-9542-beab24e7474f 37 fields · synced Jun 8, 2026