Catalog Number

3565

Brand Name

ACCUMED

Version/Model Number

IPN001467

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

IQI

Product Code Name

ORTHOSIS, LIMB BRACE

Public Device Record Key

5f2c71d3-faad-43f6-9768-bf6784f6906e

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

January 27, 2020

Package DI Number

20841156105645

Quantity per Package

10

Contains DI Package

10841156105648

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box