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Intermittent Catheter

FDA UDI

Class II (US FDA UDI)

by Dynarex Corp.

Identity

Trade Name
Intermittent Catheter FDA UDI
Generic Name
Single-administration urethral drainage/irrigation catheter FDA UDI
Model / Reference
4985 FDA UDI

Identifiers

Primary DI / UDI-DI
00616784498522 FDA UDI
510(k) Number
K103086 FDA UDI
FDA Product Code
EZD FDA UDI
GMDN Term
Single-administration urethral drainage/irrigation 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

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

Yes

FDA UDI

Category: Single-administration urethral drainage/irrigation catheter

Intermittent Catheter by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-administration urethral drainage/irrigation catheter.

Cleared under the same submission

K103086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynarex Corp.

Sources (1)

  • FDA UDI cfcb81d2-e75d-40b9-b307-013782ac86ad 33 fields · synced May 31, 2026