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Cer-Sub-1111-Ot-Bnt
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 74387-01MModel RAN
by Ranfac Corp.
Identity
- Trade Name
- CER-SUB-1111-OT-BNT EUDAMEDFDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- Ranfac Bone Marrow Aspiration Needle EUDAMEDCER-SUB-1111-OT-BNT PN: 74387-01M FDA UDI
- Model / Reference
- RAN EUDAMED74387-01M EUDAMED11 GA X 11CM FDA UDI
- Description
- CER-SUB-1111-OT-BNT PN: 74387-01M FDA UDI
Identifiers
- Catalog Number
- CER-SUB-1111-OT-BNT FDA UDI
- Primary DI / UDI-DI
- 00850023741387 EUDAMEDFDA UDI
- Basic UDI-DI
- 08586900068300101G5 EUDAMED
- Direct Marketing DI
- 00850023741387 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
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 — 11 Centimeter FDA UDINeedle Gauge — 11 Gauge FDA UDI
Cer-Sub-1111-Ot-Bnt by Ranfac Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 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 0f6f3ae3-3eec-4fa3-9f47-a7a4deeb423e 61 fields · synced Jun 8, 2026
- FDA UDI 837300e0-7d7f-4d9e-b4ef-b91454cf8645 37 fields · synced May 30, 2026