Identity
- Trade Name
- Exodus FDA UDI
- Generic Name
- Nephrostomy catheter FDA UDI
- Device Name
- 10F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating FDA UDI
- Model / Reference
- 10415 FDA UDI
- Description
- 10F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating FDA UDI
Identifiers
- Primary DI / UDI-DI
- H965104150 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Nephrostomy catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
Dimensions & Sizes
- Size
- Outer Diameter — 3.4 Millimeter FDA UDICatheter Gauge — 10 French FDA UDILength — 25 Centimeter FDA UDI
Exodus by Navilyst Medical, Inc. — 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
- Navilyst Medical, Inc.
Sources (1)
- FDA UDI 7d4be09a-c2e6-41b1-8f47-35619c5d0f10 36 fields · synced May 31, 2026