Identity
- Trade Name
- PMI FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram Catheter 20" & (PIN-15) Disposable Percutaneous Introducer 4" length and 14 gauge FDA UDI
- Model / Reference
- PMIORCAP20 FDA UDI
- Description
- For Percutaneous Insertion, Combo Pack Includes:(PMIORCA20) Disposable Operative Cholangiogram Catheter 20" & (PIN-15) Disposable Percutaneous Introducer 4" length and 14 gauge FDA UDI
Identifiers
- Catalog Number
- PMIORCAP20 FDA UDI
- Primary DI / UDI-DI
- 00812608020980 FDA UDI
- FDA Product Code
- GBZ FDA UDI
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pmi by Progressive Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Progressive Medical, Inc.
Sources (1)
- FDA UDI 2dd97b32-e2f3-4295-a6db-a0333985ae75 36 fields · synced May 30, 2026