Neuray®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: Neuray® FDA UDI
Generic Name: Radiopaque woven surgical sponge FDA UDI
Device Name: PACKING 8004008 NEURAY 200PK 25X76MM FDA UDI
Model / Reference: 8004008 FDA UDI
Description: PACKING 8004008 NEURAY 200PK 25X76MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000032852 FDA UDI
510(k) Number: K923027 FDA UDI
FDA Product Code: HBA FDA UDI
GMDN Term: Radiopaque woven surgical sponge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4700 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 76.0 Millimeter FDA UDI
Length — 1.0 Inch FDA UDI
Width — 3.0 Inch FDA UDI
Length — 25.0 Millimeter FDA UDI

Category: Radiopaque woven surgical sponge

Neuray® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiopaque woven surgical sponge.

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ORLocate — STERIS CORPORATION · Class I
Kerlix — Cardinalhealth · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
AMD-RITMED — AMD Medicom Inc · Class I
Dukal — Dukal LLC · Class I

Cleared under the same submission

K923027 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: Medtronic Xomed, Inc.

Sources (1)

FDA UDI e14235fb-4e2f-4a95-9329-89e6b2b8fd83 36 fields · synced Jun 7, 2026