Identity
- Trade Name
- CER-ORTHO-M FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- CER-ORTHO-M, F/G, STERILE P/N 74376-01M FDA UDI
- Model / Reference
- 11 Gauge x 6.1CM FDA UDI
- Description
- CER-ORTHO-M, F/G, STERILE P/N 74376-01M FDA UDI
Identifiers
- Catalog Number
- CER-ORTHO-M FDA UDI
- Primary DI / UDI-DI
- 00850023741158 FDA UDI
- 510(k) Number
- K150563 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — 11 Gauge FDA UDILength — 6.1 Centimeter FDA UDI
Category: Bone access cannula
Cer-Ortho-M by Ranfac Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K150563 also covers:
- CELLXTRACT Autologous Cell and Bone Marrow Extraction — RANFAC CORP.
- CER-EXT — RANFAC CORP.
- CER-LA-M — RANFAC CORP.
- Cervos Extremity Bone Marrow Aspiration Needle — RANFAC CORP.
- Cervos Extremity Manual Bone Marrow Aspiration Needle — RANFAC CORP.
- Cervos Flex Bone Marrow Aspiration Needle — RANFAC CORP.
- Cervos Foot and Ankle Bone Marrow Aspiration Needle — RANFAC CORP.
- Cervos Orthopedic Bone Marrow Aspiration Needle, Sterile, F/G — RANFAC CORP.
- MAXX-CELL — RANFAC CORP.
- MAXX-CELL-3 — RANFAC CORP.
- MAXX-REGEN — RANFAC CORP.
- MC-RAN 13A, RJN-84 — RANFAC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
Sources (2)
- FDA UDI 5cd2cde0-b3b7-443a-9f43-1d808bfa7327 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026