Identity
- Trade Name
- M-Biopsy Needle For Reusable Biopsy Instruments FDA UDI
- Generic Name
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
- Device Name
- The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with a Pro-Mag™ Automatic Biopsy Instrument. FDA UDI
- Model / Reference
- N20216016 FDA UDI
- Description
- The M-Biopsy biopsy needle is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with a Pro-Mag™ Automatic Biopsy Instrument. FDA UDI
Identifiers
- Catalog Number
- N20216016 FDA UDI
- Primary DI / UDI-DI
- 15711055001455 FDA UDI
- FDA Product Code
- DWO FDA UDI
- GMDN Term
- Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 16 Gauge FDA UDILength — 16 Centimeter FDA UDI
Category: Soft-tissue biopsy procedure kit, non-medicated
M-Biopsy Needle For Reusable Biopsy Instruments by Mermaid Medical A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Mermaid Medical A/S
Sources (1)
- FDA UDI 70f36f9c-f14e-4f15-b458-19ce4e0557fc 37 fields · synced Jun 1, 2026