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Rusch

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
RUSCH FDA UDI
Generic Name
Urodynamic catheter FDA UDI
Device Name
Twin Lumen Catheter FDA UDI
Model / Reference
IPN052237 FDA UDI
Description
Twin Lumen Catheter FDA UDI

Identifiers

Catalog Number
395767-000100 FDA UDI
Primary DI / UDI-DI
04026704052479 FDA UDI
FDA Product Code
FEN FDA UDI
GMDN Term
Urodynamic catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1620 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

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

Dimensions & Sizes

Size
Outer Diameter — 3.3 Millimeter FDA UDI

Category: Urodynamic catheter

Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urodynamic catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 8c5dea54-22af-45eb-8c88-757df13cbafd 36 fields · synced May 30, 2026