Identity
- Trade Name
- MONOPTY FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- MONOPTY® Disposable Core Biopsy Instrument Kit, 14g x 16cm FDA UDI
- Model / Reference
- 000441 FDA UDI
- Description
- MONOPTY® Disposable Core Biopsy Instrument Kit, 14g x 16cm FDA UDI
Identifiers
- Catalog Number
- 000441 FDA UDI
- Primary DI / UDI-DI
- 00801741084553 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Side-notch biopsy gun handpiece/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
Yes
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
- Needle Gauge — 14 Gauge FDA UDILength — 16 Centimeter FDA UDI
Monopty 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 5267982f-1370-41e6-90cb-da298d1b241d 37 fields · synced May 31, 2026