Catalog Number

-

Brand Name

SAM Soft Shell Splint

Version/Model Number

SS542-EN

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

NOC

Product Code Name

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

Public Device Record Key

7c1cfb95-c851-44ee-982c-4d6635f5dfef

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

10822045428833

Quantity per Package

20

Contains DI Package

00822045428836

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case