Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Single-administration urethral drainage catheter FDA UDI
- Device Name
- Word Catheter, Sterile FDA UDI
- Model / Reference
- IPN052734 FDA UDI
- Description
- Word Catheter, Sterile FDA UDI
Identifiers
- Catalog Number
- 564000 FDA UDI
- Primary DI / UDI-DI
- 04026704306206 FDA UDI
- FDA Product Code
- GBA FDA UDI
- GMDN Term
- Single-administration urethral drainage catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Single-administration urethral drainage catheter
Rusch by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-administration urethral drainage catheter.
- CURE ULTRA MALE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
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- Self-Cath — Coloplast A/S · Class II
- CURE CATHETER — CONVATEC, PURCHASING DEPARTMENT · Class II
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 5666f195-500b-45da-8637-532eced03ed3 35 fields · synced Jun 8, 2026