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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Surgical irrigation/aspiration handpiece, single-use FDA UDI
Device Name
6FR 1.5ML CATH W/3ML STER WATE FDA UDI
Model / Reference
URO2S0615K FDA UDI
Description
6FR 1.5ML CATH W/3ML STER WATE FDA UDI

Identifiers

Catalog Number
URO2S0615K FDA UDI
Primary DI / UDI-DI
10888277561304 FDA UDI
FDA Product Code
OHR FDA UDI
GMDN Term
Surgical irrigation/aspiration handpiece, 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

No

FDA UDI

Category: Surgical irrigation/aspiration handpiece, single-use

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration handpiece, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 708e147a-1f96-4528-8caa-74fb7ce3a058 36 fields · synced May 30, 2026