Identity
- Trade Name
- AV Sheath Tunneler FDA UDI
- Generic Name
- Vascular graft tunneller FDA UDI
- Device Name
- AV Sheath Tunneler Sterilization Cassette FDA UDI
- Model / Reference
- AVST0100 FDA UDI
- Description
- AV Sheath Tunneler Sterilization Cassette FDA UDI
Identifiers
- Catalog Number
- AVST0100 FDA UDI
- Primary DI / UDI-DI
- 00801741090516 FDA UDI
- 510(k) Number
- K042062 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Vascular graft tunneller FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
AV Sheath Tunneler 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 e731fae3-53c9-409d-b75d-72dd0a23ee9e 37 fields · synced Jun 1, 2026