Ranfac Bone Marrow Aspiration Needle
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by Ranfac Corp.
Identity
- Trade Name
- Ranfac Bone Marrow Aspiration Needle EUDAMEDRAN-8 FDA UDIMC-RAN-11C, STERILE F/G FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Ranfac Bone Marrow Aspiration Needle EUDAMEDRAN-8, SF, F/G, STERILE, RANFAC P/N 74171-11M FDA UDIMC-RAN-11C, STERILE F/G PN 74303-01M MARROW CELLUTIONS ASPIRATION NEEDLE, DOUBLE POUCHED FDA UDI
- Model / Reference
- RAN EUDAMEDRAN-11 EUDAMEDMC-RAN EUDAMED8GA X 11CM FDA UDI11 Gauge x 9CM FDA UDI
- Description
- RAN-8, SF, F/G, STERILE, RANFAC P/N 74171-11M FDA UDIMC-RAN-11C, STERILE F/G PN 74303-01M MARROW CELLUTIONS ASPIRATION NEEDLE, DOUBLE POUCHED FDA UDI
Identifiers
- Catalog Number
- RAN-8 FDA UDIMC-RAN-11C FDA UDI
- Primary DI / UDI-DI
- 00857878007774 EUDAMEDFDA UDI00857878007194 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300101G5 EUDAMED
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Bone access cannula 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Needle Gauge — 8 Gauge FDA UDILength — 11 Centimeter FDA UDINeedle Gauge — 11 Gauge FDA UDILength — 9 Centimeter FDA UDI
Category: Diskectomy system, percutaneous, automatic
Ranfac Bone Marrow Aspiration Needle by Ranfac Corp. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131157 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08586900068300101G5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ranfac Corp.
- EUDAMED SRN
- US-MF-000008871
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 444dc5a3-4e96-4b27-970c-c98462700186 61 fields · synced Jul 13, 2026
- FDA UDI d160d7d4-3d29-4561-b0d5-a931d6526c25 38 fields · synced May 29, 2026
- FDA UDI 6d863b7e-e48e-45f6-9773-2cc79a3254ba 37 fields · synced May 30, 2026
- EUDAMED 2c806740-9b07-4b17-855a-2a50be69748a 61 fields · synced Jul 13, 2026
- FDA 510(k) K131157 1 fields · synced May 18, 2026