Identity
- Trade Name
- PROFORMA FDA UDI
- Generic Name
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
- Device Name
- PROFORMA Cannula, Standard Tip, Straight FDA UDI
- Model / Reference
- 050300 FDA UDI
- Description
- PROFORMA Cannula, Standard Tip, Straight FDA UDI
Identifiers
- Catalog Number
- 050300 FDA UDI
- Primary DI / UDI-DI
- 20653405051272 FDA UDI
- 510(k) Number
- K950700 FDA UDI
- FDA Product Code
- ODD FDA UDI
- GMDN Term
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Centimeter FDA UDICatheter Gauge — 5 French FDA UDIOuter Diameter — 0.035 Inch FDA UDIOuter Diameter — 0.89 Millimeter FDA UDI
Proforma by Conmed Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (1)
- FDA UDI fd3d9723-6119-4119-9d8f-2f147948ff66 38 fields · synced May 31, 2026