Identity
- Trade Name
- STIFFENING CANNULA, 9CM F/G FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- STIFFENING CANNULA, 9CM F/G SC-9CM PN 60001-07M FDA UDI
- Model / Reference
- 9CM FDA UDI
- Description
- STIFFENING CANNULA, 9CM F/G SC-9CM PN 60001-07M FDA UDI
Identifiers
- Catalog Number
- SC-9CM FDA UDI
- Primary DI / UDI-DI
- 00858690006655 FDA UDI
- 510(k) Number
- K845038 FDA UDI
- FDA Product Code
- GDF FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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 — 9 Centimeter FDA UDINeedle Gauge — 23 Gauge FDA UDI
Category: Needle guide, single-use
Stiffening Cannula, 9cm F/G by Ranfac Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Cleared under the same submission
K845038 also covers:
- RANFAC BREAST MRK, 10CM F/G SBS-10 — RANFAC CORP.
- RANFAC BREAST MRK, 5CM F/G — RANFAC CORP.
- RANFAC BREAST MRK, 7.5CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 3CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 4CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 5CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 6CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 7CM F/G — RANFAC CORP.
- STIFFENING CANNULA, 8CM F/G — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ranfac Corp.
Sources (1)
- FDA UDI 92cee43c-8e80-4ecb-87c7-890d34198622 37 fields · synced Jun 8, 2026