Catalog Number

-

Brand Name

Well at Walgreens

Version/Model Number

307746

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

0ee5d0c6-e52f-4bd1-9d8b-f22ea255c192

Public Version Date

June 08, 2020

Public Version Number

1

DI Record Publish Date

May 29, 2020

Package DI Number

10049022739229

Quantity per Package

12

Contains DI Package

00049022739222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack