Identity
- Trade Name
- WECK FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- WECK EFx Shield Port Site Closure System FDA UDI
- Model / Reference
- IPN011977 FDA UDI
- Description
- WECK EFx Shield Port Site Closure System FDA UDI
Identifiers
- Catalog Number
- EFX002 FDA UDI
- Primary DI / UDI-DI
- 04026704552078 FDA UDI
- FDA Product Code
- HCF FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Dimensions & Sizes
- Size
- Length — 7.9 Inch FDA UDI
Category: Suturing unit, single-use
Weck by Teleflex Incorporated — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 9b5a72b9-1f54-411c-823a-bf3de8ef1cb4 36 fields · synced May 30, 2026