Catalog Number

Not Applicable

Brand Name

MedSource Flex-All Splint

Version/Model Number

MS-SPLINT

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILH

Product Code Name

Splint, Hand, And Components

Public Device Record Key

6937b250-f119-434e-8cad-80d5b9c41bf9

Public Version Date

August 20, 2021

Public Version Number

1

DI Record Publish Date

August 12, 2021

Package DI Number

00816703027448

Quantity per Package

100

Contains DI Package

00816703027431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case