Mueller Aircast Ankle Brace Right White - AIRCAST ANKLE BRACE - RIGHT, WHITE - Mueller Sports Medicine, Inc.

Duns Number:006426316

Device Description: AIRCAST ANKLE BRACE - RIGHT, WHITE

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More Product Details

Catalog Number

4566

Brand Name

Mueller Aircast Ankle Brace Right White

Version/Model Number

4566

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FZF

Product Code Name

SPLINT, EXTREMITY, INFLATABLE, EXTERNAL

Device Record Status

Public Device Record Key

8edc2573-cb39-4c20-b3f1-1cd8c2064bbb

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MUELLER SPORTS MEDICINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148
2 A medical device with a moderate to high risk that requires special controls. 15