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Ureteral Catheter Administration Kit

FDA UDI

Class II (US FDA UDI)

by Urogen Pharma, Ltd.

Identity

Trade Name
Ureteral Catheter Administration Kit FDA UDI
Generic Name
Urological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains: • Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL • One (1) Ureteral Catheter, 7 Fr FDA UDI
Model / Reference
UCAK FDA UDI
Description
The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The Ureteral Catheter Administration Kit contains: • Two (2) Syringe Adaptors • Two (2) Syringes, 20 mL • One (1) Ureteral Catheter, 7 Fr FDA UDI

Identifiers

Catalog Number
200006 FDA UDI
Primary DI / UDI-DI
10854913006096 FDA UDI
FDA Product Code
OHR FDA UDI
GMDN Term
Urological surgical procedure kit, non-medicated, single-use 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Urological surgical procedure kit, non-medicated, single-use

Ureteral Catheter Administration Kit by Urogen Pharma, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urological surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urogen Pharma, Ltd.

Sources (1)

  • FDA UDI 409d14a2-8ad6-4a9c-81c3-97c79f3513d1 36 fields · synced May 30, 2026