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 coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument. FDA UDI
- Model / Reference
- N20418020 FDA UDI
- Description
- The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument. FDA UDI
Identifiers
- Catalog Number
- N20418020 FDA UDI
- Primary DI / UDI-DI
- 15711055001721 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 — 18 Gauge FDA UDILength — 20 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 87380191-dcfb-45c2-828d-bc3001f13e7e 37 fields · synced Jun 8, 2026