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Cer-Bn-84
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 74361-01MModel Ranfac Marrow Biopsy Needle
by Ranfac Corp.
Identity
- Trade Name
- CER-BN-84 EUDAMEDFDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- RBN-84 EUDAMEDCER-BN-84 PN: 74361-01M FDA UDI
- Model / Reference
- Ranfac Marrow Biopsy Needle EUDAMED74361-01M EUDAMED8 GA X 4 IN FDA UDI
- Description
- CER-BN-84 PN: 74361-01M FDA UDI
Identifiers
- Catalog Number
- CER-BN-84 FDA UDI
- Primary DI / UDI-DI
- 00850023741318 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300701H3 EUDAMED
- Direct Marketing DI
- 00850023741318 EUDAMED
- 510(k) Number
- K983187 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A010299 BIOPSY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 8 Gauge FDA UDILength — 4 Inch FDA UDI
Category: Needle guide, single-use
Cer-Bn-84 by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08586900068300701H3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
- EUDAMED SRN
- US-MF-000008871
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 94709043-b606-46e5-83b2-7bf9e9e1e14a 61 fields · synced Jul 27, 2026
- FDA UDI 4dc1a575-6d33-49c9-9fef-e1e289fa519c 37 fields · synced May 26, 2026