Identity
- Trade Name
- WECK EFx Shield Port Site Closure System EUDAMEDWECK FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- WECK® EFx Shield™ Fascial Closure System EUDAMEDWECK EFx Shield Port Site Closure System FDA UDI
- Model / Reference
- EFX002 EUDAMEDIPN917216 FDA UDI
- Description
- WECK EFx Shield Port Site Closure System FDA UDI
Identifiers
- Catalog Number
- EFX002 FDA UDI
- Primary DI / UDI-DI
- 14026704736321 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000031K3 EUDAMED
- FDA Product Code
- HCF FDA UDI
- EMDN Code
- H9099 SUTURE DEVICES - OTHER EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland 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
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI 63cf5a2e-aa29-49f9-9a5d-a47f73007c7a 36 fields · synced Jun 19, 2026
- EUDAMED b86f1c50-5494-405d-92b7-aebdcf6dfcff 61 fields · synced Jun 19, 2026