Catalog Number

-

Brand Name

SAM Splint

Version/Model Number

SP527-CH-EN-773

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

NOC

Product Code Name

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

Public Device Record Key

619062fa-5700-4fc8-a53a-00b5e1341c6a

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

10822045000435

Quantity per Package

60

Contains DI Package

00822045000438

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case