Game Ready - Sleeve, Full Leg Boot, Large - Avanos Medical, Inc.

Duns Number:079375431

Device Description: Sleeve, Full Leg Boot, Large

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More Product Details

Catalog Number

-

Brand Name

Game Ready

Version/Model Number

510922

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Device Record Status

Public Device Record Key

be7ef94b-16dc-4dab-9114-a6144c1b5e14

Public Version Date

May 20, 2021

Public Version Number

5

DI Record Publish Date

May 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221