Catalog Number

Not Applicable

Brand Name

MedSource Immobilizer

Version/Model Number

BT-91012

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

b19dbf91-c3c2-4cfc-8aaf-c9ca006f7740

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

00840155408517

Quantity per Package

50

Contains DI Package

00840155408500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case