Identity
- Trade Name
- Franseen FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Franseen Lung Biopsy Needle FDA UDI
- Model / Reference
- G01269 FDA UDI
- Description
- Franseen Lung Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- DFBN-22-20.0 FDA UDI
- Primary DI / UDI-DI
- 00827002012691 FDA UDI
- FDA Product Code
- MJG FDA UDI
- GMDN Term
- Body aspiration needle, single-use 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
Category: Body aspiration needle, single-use
Franseen by Cook, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
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- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA UDI 97c8fd1d-c87f-41c7-afb6-8f1144d2c8c2 36 fields · synced Jun 6, 2026