Identity
- Trade Name
- CER-BN-116 FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- Cervos 11GA Biopsy Needle P/N: 74365-01M Customer #: 12153 FDA UDI
- Model / Reference
- 11GA X 6" FDA UDI
- Description
- Cervos 11GA Biopsy Needle P/N: 74365-01M Customer #: 12153 FDA UDI
Identifiers
- Catalog Number
- CER-BN-116 FDA UDI
- Primary DI / UDI-DI
- 00850023741066 FDA UDI
- 510(k) Number
- K983187 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone marrow 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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 11 Gauge FDA UDILength — 6 Inch FDA UDI
Category: Bone marrow biopsy needle, single-use
Cer-Bn-116 by Ranfac Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Faset — Dio Medical Co., Ltd. · U
- BMN J TYPE — H.S. HOSPITAL SERVICE SPA · Class II
Cleared under the same submission
K983187 also covers:
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- Monoject — Cardinalhealth
- BMET-11, F/G — RANFAC CORP.
- BMET-11-2, 2% LIDOCAINE — RANFAC CORP.
- BMET-11A, F/G — RANFAC CORP.
- BMET-11AL — RANFAC CORP.
- BMET-11ANL, F/G — RANFAC CORP.
- BMET-11NL, F/G — RANFAC CORP.
- BMET-8A — RANFAC CORP.
- BMT-11B, F/G — RANFAC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
Sources (2)
- FDA UDI 34344b12-8bf2-421b-b68b-08bac6d60226 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026