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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 8004001 NEURAY 200PK 19X19MM FDA UDI
Model / Reference
8004001 FDA UDI
Description
PACKING 8004001 NEURAY 200PK 19X19MM FDA UDI

Identifiers

Primary DI / UDI-DI
20681490171537 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
Not 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 19.0 Millimeter FDA UDI
Length — 19.0 Millimeter FDA UDI

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

Cleared under the same submission

K923027 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI d9575e80-041a-4c61-8dd8-c8efcac94761 37 fields · synced Jun 1, 2026