Identity
- Trade Name
- MONOPTY FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- MONOPTY® Disposable Core Biopsy Instrument, 11mm penetration depth, 20g x 19cm FDA UDI
- Model / Reference
- 212020 FDA UDI
- Description
- MONOPTY® Disposable Core Biopsy Instrument, 11mm penetration depth, 20g x 19cm FDA UDI
Identifiers
- Catalog Number
- 212020 FDA UDI
- Primary DI / UDI-DI
- 00801741084799 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
- 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 — 19 Centimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: Side-notch biopsy gun handpiece/needle
Monopty by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
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 cfc98705-b6f8-4433-aa59-2360b184d5fd 36 fields · synced May 31, 2026