Ran-1115n5b
EUDAMEDFDA UDIClass IIa (EU MDR)
by Ranfac Corp.
Identity
- Trade Name
- RAN-1115N5B EUDAMEDFDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Ranfac Bone Marrow Aspiration Needle EUDAMEDNEEDLE, RAN-1115N5B F/G, STERILE, CE P/N: 74354-01M FDA UDI
- Model / Reference
- RAN EUDAMED74354-01M EUDAMED11Ga x 15CM FDA UDI
- Description
- NEEDLE, RAN-1115N5B F/G, STERILE, CE P/N: 74354-01M FDA UDI
Identifiers
- Catalog Number
- RAN-1115N5B FDA UDI
- Primary DI / UDI-DI
- 00857878007972 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300101G5 EUDAMED
- Direct Marketing DI
- 00857878007972 EUDAMED
- 510(k) Number
- K131157 FDA UDI
- 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
- Germany 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
Yes
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 — 11 Gauge FDA UDILength — 15 Centimeter FDA UDI
Category: Diskectomy system, percutaneous, automatic
Ran-1115n5b by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08586900068300101G5 | 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 25fabb5e-cc28-4544-9c03-db36c7c9c0ad 61 fields · synced Jul 24, 2026
- FDA UDI 648708cf-0a64-471a-af5f-d0ec380f9650 38 fields · synced May 30, 2026