Catalog Number

-

Brand Name

Coretech

Version/Model Number

SUP1039

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)

Yes

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

07240cf2-1f7a-4d0b-b9bb-f1a879a69589

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

Package DI Number

10810041987881

Quantity per Package

24

Contains DI Package

00810041987884

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case