Identity
- Trade Name
- RAN-11 #0016008 FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Device Name
- RAN-11 PN 74285-01M Customer# 0016008 FDA UDI
- Model / Reference
- 11 Gauge x 11cm FDA UDI
- Description
- RAN-11 PN 74285-01M Customer# 0016008 FDA UDI
Identifiers
- Catalog Number
- 74285-01M FDA UDI
- Primary DI / UDI-DI
- 00858690006020 FDA UDI
- 510(k) Number
- K131157 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
Ran-11 #0016008 by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131157 also covers:
- 18-40-0231, F/G, STERILE — RANFAC CORP.
- MC-RAN-13FA — RANFAC CORP.
- MC-RAN-13FA — RANFAC CORP.
- NEEDLE, RAN-1111H5T, F/G, STERILE, RANFAC — RANFAC CORP.
- RAN-11 — RANFAC CORP.
- RAN-11, F/G — RANFAC CORP.
- RAN-11-1 — RANFAC CORP.
- RAN-1113-OT — RANFAC CORP.
- RAN-1115 — RANFAC CORP.
- RAN-1115 #0016008 — RANFAC CORP.
- RAN-1115-204 — RANFAC CORP.
- RAN-1115H5T-BNT — 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 b54e0b53-ed74-46ea-a9e2-bf6ff23a7444 37 fields · synced May 30, 2026