Identity
- Trade Name
- Bard FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- Bard CK Parastomal Hernia Patch Size: 6.1" x 8.1" Stoma Opening Diameter: 1.4"-1.8" FDA UDI
- Model / Reference
- 0118004 FDA UDI
- Description
- Bard CK Parastomal Hernia Patch Size: 6.1" x 8.1" Stoma Opening Diameter: 1.4"-1.8" FDA UDI
Identifiers
- Catalog Number
- 0118004 FDA UDI
- Primary DI / UDI-DI
- 00801741031137 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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 — 6.1 Inch FDA UDIWidth — 8.1 Inch FDA UDI
Bard by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Davol Inc.
Sources (1)
- FDA UDI 4231e4d6-d00d-4b9a-91bb-b8bbd5e3aab3 37 fields · synced Jun 6, 2026