Identity
- Trade Name
- MC-RAN-11CSTS, STERILE F/G FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- MC-RAN-11CSTS, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74279-02M FDA UDI
- Model / Reference
- 11 Gauge X 11CM FDA UDI
- Description
- MC-RAN-11CSTS, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74279-02M FDA UDI
Identifiers
- Catalog Number
- 74279-02M FDA UDI
- Primary DI / UDI-DI
- 00858690006013 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
- Length — 11 Centimeter FDA UDINeedle Gauge — 11 Gauge FDA UDI
Category: Bone access cannula
Mc-Ran-11csts, Sterile F/G by Ranfac Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bone access cannula.
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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.
- CER-ORTHO-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.
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 063c112c-8cee-4214-bc1c-9ef7bd9113f1 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026