Catalog Number

30-124-00

Brand Name

O.R. Foam Positioners

Version/Model Number

30-124-00

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

Yes

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

CCX

Product Code Name

Support, Patient Position

Public Device Record Key

69da50ca-a6f4-4094-ba31-54277f39732d

Public Version Date

July 15, 2020

Public Version Number

2

DI Record Publish Date

February 24, 2020

Package DI Number

00810044960242

Quantity per Package

12

Contains DI Package

10810044960249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case