← Back to catalogue
Rbn-116
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 74049-02MModel Ranfac Marrow Biopsy Needle
by Ranfac Corp.
Identity
- Trade Name
- RBN-116 EUDAMEDRBN-116, F/G, STERILE FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- RBN-84 EUDAMEDRBN-116, F/G, STERILE P/N 74049-02M FDA UDI
- Model / Reference
- Ranfac Marrow Biopsy Needle EUDAMED74049-02M EUDAMED11 Gauge X 6" FDA UDI
- Description
- RBN-116, F/G, STERILE P/N 74049-02M FDA UDI
Identifiers
- Catalog Number
- RBN-116 FDA UDI
- Primary DI / UDI-DI
- 00858690006389 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300701H3 EUDAMED
- Direct Marketing DI
- 00858690006389 EUDAMED
- 510(k) Number
- K983187 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS 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
- Germany 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
- Length — 6 Inch FDA UDINeedle Gauge — 11 Gauge FDA UDI
Category: Bone marrow biopsy needle, single-use
Rbn-116 by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ranfac Corp.
- EUDAMED SRN
- US-MF-000008871
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f08eccf8-f58c-41c7-a972-e6fcd2143311 61 fields · synced Jul 14, 2026
- FDA UDI d269566d-d22a-45ba-9fc4-db3812fe4a11 37 fields · synced May 26, 2026