Avanos

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name: AVANOS FDA UDI
Generic Name: Manual epidural space locator FDA UDI
Device Name: 5CCSYR,GLSSYR FDA UDI
Model / Reference: 92409 FDA UDI
Description: 5CCSYR,GLSSYR FDA UDI

Identifiers

Catalog Number: 18907 FDA UDI
Primary DI / UDI-DI: 00193493924097 FDA UDI
510(k) Number: K941562 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Manual epidural space locator 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual epidural space locator

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

Similar devices

Also classified as Manual epidural space locator.

EXMOOR — Exmoor Plastics , Ltd. · Class II
Halyard — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II

Cleared under the same submission

K941562 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Avanos Medical, Inc.

Sources (1)

FDA UDI 50e5bc7e-69e6-4746-8499-535fa0fa774e 36 fields · synced Jun 9, 2026