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Game Ready

FDA UDI

Class II (US FDA UDI)

by Avanos Medical, Inc.

Identity

Trade Name
Game Ready FDA UDI
Generic Name
Circulating-fluid localized thermal/compression therapy system wrap FDA UDI
Device Name
Straight Knee Wrap* with ATX (one size fits all) FDA UDI
Model / Reference
590100-03 FDA UDI
Description
Straight Knee Wrap* with ATX (one size fits all) FDA UDI

Identifiers

Primary DI / UDI-DI
00812120000651 FDA UDI
FDA Product Code
ILO FDA UDI
IRP FDA UDI
GMDN Term
Circulating-fluid localized thermal/compression therapy system wrap FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 FDA UDI
890.5650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Circulating-fluid localized thermal/compression therapy system wrap

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

Similar devices

Also classified as Circulating-fluid localized thermal/compression therapy system wrap.

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 6a3c5f06-2ef1-4375-89e7-74a9e4b4f5e3 33 fields · synced Jun 9, 2026