Identity
- Trade Name
- PERCUTANEOUS INTRO NEEDLE F/G FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Device Name
- PERCUTANEOUS INTRO NEEDLE F/G PIN-15 75010-01M FDA UDI
- Model / Reference
- PIN-15 FDA UDI
- Description
- PERCUTANEOUS INTRO NEEDLE F/G PIN-15 75010-01M FDA UDI
Identifiers
- Catalog Number
- PIN-15 FDA UDI
- Primary DI / UDI-DI
- 00858690006433 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Non-vascular catheter introduction set
Percutaneous Intro Needle F/G by Ranfac Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-vascular catheter introduction set.
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- Amplatz — COOK INCORPORATED · Class II
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
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 03f580ca-75fc-416d-9578-408201e6aa34 36 fields · synced Jun 8, 2026