Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Hydrogel Coated Latex Foley Catheter Coude Tip, 5 mL, 2-Way, Red FDA UDI
- Model / Reference
- 1516C FDA UDI
- Description
- Hydrogel Coated Latex Foley Catheter Coude Tip, 5 mL, 2-Way, Red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521016071 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
No
FDA UDI
Over-the-Counter
Yes
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
- Catheter Gauge — 16 French FDA UDITotal Volume — 5 Milliliter FDA UDI
Category: Single-administration urethral drainage catheter
Dover by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
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- Apogee Plus — Hollister Incorporated · Class II
- Magic3™ Intermittent Catheter — C. R. Bard, Inc. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
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
- Cardinalhealth
Sources (1)
- FDA UDI c48d6f83-0a2c-450d-b4b2-a15ae1080813 36 fields · synced Jun 8, 2026