AIR TRIO SHELL WALKER LOW TOP LG/XL - Bird & Cronin, LLC

Duns Number:045975349

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More Product Details

Catalog Number

-

Brand Name

AIR TRIO SHELL WALKER LOW TOP LG/XL

Version/Model Number

08140994

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

Yes

Prescription Use (Rx)

-

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

ITW

Product Code Name

Joint, Ankle, External Brace

Device Record Status

Public Device Record Key

ad7bd1f8-8815-4899-907f-293725912b8a

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIRD & CRONIN, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2022