Identity
- Trade Name
- BARD® FDA UDI
- Generic Name
- Carotid artery shunt FDA UDI
- Device Name
- BARD® Carotid Bypass Shunt, Straight Carotid Shunt, 14F x 13cm FDA UDI
- Model / Reference
- 000675 FDA UDI
- Description
- BARD® Carotid Bypass Shunt, Straight Carotid Shunt, 14F x 13cm FDA UDI
Identifiers
- Catalog Number
- 000675 FDA UDI
- Primary DI / UDI-DI
- 00801741090059 FDA UDI
- FDA Product Code
- DWF FDA UDI
- GMDN Term
- Carotid artery shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4210 FDA UDI
- Commercial Distribution
- Not 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
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 — 13 Centimeter FDA UDI
Bard® 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 44f0b522-969d-4158-8091-7ae8acad273f 37 fields · synced May 31, 2026