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Avanos

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
AVANOS FDA UDI
Generic Name
External pledget FDA UDI
Device Name
5CCSYR,GLSSYR FDA UDI
Model / Reference
92410 FDA UDI
Description
5CCSYR,GLSSYR FDA UDI

Identifiers

Catalog Number
18908 FDA UDI
Primary DI / UDI-DI
00193493924103 FDA UDI
510(k) Number
K941562 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
External pledget FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 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

No

FDA UDI

Category: External pledget

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

Similar devices

Also classified as External pledget.

Cleared under the same submission

K941562 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avanos Medical, Inc.

Sources (1)

  • FDA UDI 7f3fea54-b0ad-4987-a473-f9225297c08b 36 fields · synced Jun 9, 2026