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Dover

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
Dover FDA UDI
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Device Name
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 16 FR (5.3 MM), RED LATES FDA UDI
Model / Reference
1516C FDA UDI
Description
HYDROGEL COATED LATEX FOLEY CATHETER, COUDE TIP, 5 CC, 2-WAY, 16 FR (5.3 MM), RED LATES FDA UDI

Identifiers

Catalog Number
1516C FDA UDI
Primary DI / UDI-DI
10192253027433 FDA UDI
FDA Product Code
EZL FDA UDI
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 8d7895eb-b590-436e-b24b-b68651c375ed 34 fields · synced Jun 6, 2026