Identity
- Trade Name
- BIOPTY-CUT FDA UDI
- Generic Name
- Side-notch biopsy gun needle FDA UDI
- Device Name
- BIOPTY-CUT® Disposable Core Biopsy Needle with Spacer, 16g x 16cm FDA UDI
- Model / Reference
- 451616 FDA UDI
- Description
- BIOPTY-CUT® Disposable Core Biopsy Needle with Spacer, 16g x 16cm FDA UDI
Identifiers
- Catalog Number
- 451616 FDA UDI
- Primary DI / UDI-DI
- 00801741084126 FDA UDI
- FDA Product Code
- KNW FDA UDIFCG FDA UDI
- GMDN Term
- Side-notch biopsy gun needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
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 — 16 Centimeter FDA UDINeedle Gauge — 16 Gauge FDA UDI
Biopty-Cut 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bard Peripheral Vascular
Sources (1)
- FDA UDI 21cce2b7-b23e-47ed-a03d-b3afbf8be7a7 37 fields · synced Jun 1, 2026