Catalog Number

-

Brand Name

Walgreens

Version/Model Number

931589

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"

Yes

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

512b5da1-3dc2-4c55-a951-5673eae9ffc4

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

10311917182541

Quantity per Package

36

Contains DI Package

00311917182544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case