Identity
- Trade Name
- CER-EXT FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- CER-EXT NEEDLE, F/G, STERILE, CE PN: 74395-01M FDA UDI
- Model / Reference
- 11 GA X 6.4 CM FDA UDI
- Description
- CER-EXT NEEDLE, F/G, STERILE, CE PN: 74395-01M FDA UDI
Identifiers
- Catalog Number
- CER-EXT FDA UDI
- Primary DI / UDI-DI
- 00850023741448 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 — 6.4 Centimeter FDA UDI
Category: Bone access cannula
Cer-Ext by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone access cannula.
- BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — Tecres · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Stryker — Provision · Class I
- Omnia Medical PsiF — Omnia Medical · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Omnia Medical Instruments — Omnia Medical · Class I
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
- Boston Endo Surgical Technologies LLC — LACEY MANUFACTURING COMPANY LLC · Class II
Cleared under the same submission
K150563 also covers:
- CELLXTRACT Autologous Cell and Bone Marrow Extraction — 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.
- MC-RAN 13A, RJN-84 — RANFAC CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
Sources (1)
- FDA UDI 4b857109-68b6-4d90-94f0-e46f4e1baa4e 37 fields · synced Jun 8, 2026