Identity
- Trade Name
- Bard® DeBakey® Woven Polyester Fabric FDA UDI
- Generic Name
- Cardiovascular patch, synthetic FDA UDI
- Device Name
- Bard® DeBakey® Woven Polyester Fabric, 10.2 cm x 10.2 cm FDA UDI
- Model / Reference
- 007955 FDA UDI
- Description
- Bard® DeBakey® Woven Polyester Fabric, 10.2 cm x 10.2 cm FDA UDI
Identifiers
- Catalog Number
- 007955 FDA UDI
- Primary DI / UDI-DI
- 00801741041259 FDA UDI
- FDA Product Code
- DXZ FDA UDI
- GMDN Term
- Cardiovascular patch, synthetic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3470 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
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
- Width — 10.2 Centimeter FDA UDILength — 10.2 Centimeter FDA UDI
Bard® DeBakey® Woven Polyester Fabric by Bard Peripheral Vascular — 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 |
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Manufacturer
- Manufacturer
- Bard Peripheral Vascular
Sources (1)
- FDA UDI 66c53be6-1ebc-48c9-93a0-2c85ebc70ef3 37 fields · synced Jun 6, 2026