Catalog Number

1211313

Brand Name

Redi Splint 2

Version/Model Number

Redi Splint 2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NOC

Product Code Name

Splint, Extremity, Non-Inflatable, External, Non-Sterile

Public Device Record Key

b9f4fae4-0e70-46da-926f-e101bae337e8

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-