Catalog Number

-

Brand Name

Aircast

Version/Model Number

3042

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

Issuing Agency

In GS1

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

K053575,K053575

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

c1fa3c1d-47c8-4290-a9a6-6a9958d8eabb

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30817357021111

Quantity per Package

5

Contains DI Package

10817357021117

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box