Catalog Number

0305006

Brand Name

Redicare

Version/Model Number

Redisplint Conforming Splint

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)

Yes

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

25de8351-61cb-412a-b597-aeea87fd1400

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

B70903050061

Quantity per Package

200

Contains DI Package

B70903050060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE