Identity
- Trade Name
- Franseen needle FDA UDI
- Generic Name
- Soft-tissue biopsy needle, single-use FDA UDI
- Model / Reference
- FNB-1003-20-0200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260277172602 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Soft-tissue biopsy needle, single-use 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
Yes
FDA UDI
Category: Soft-tissue biopsy needle, single-use
Franseen needle by Möller Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue biopsy needle, single-use.
- Inrad — Inrad · Class II
- CUSTOMED — Customed, Inc. · Class II
- Pro-Mag™ Biopsy Needle — Argon Medical Devices, Inc. · Class II
- CUSTOMED — Customed, Inc. · Class II
- CUSTOMED — Customed, Inc. · Class II
- Pro-Mag™ Biopsy Needle — Argon Medical Devices, Inc. · Class II
- Pro-Mag™ Biopsy Needle — Argon Medical Devices, Inc. · Class II
- SECURCUT — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Möller Medical GmbH
Sources (1)
- FDA UDI 5df9b2da-9bfc-4dcd-8696-96dfe97995cf 32 fields · synced Jun 9, 2026