Catalog Number

P-101

Brand Name

Positioning Wedges

Version/Model Number

P-101

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

cf8342cd-a1d5-454d-a2cc-dad33aa47e85

Public Version Date

July 15, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Package DI Number

00810044960549

Quantity per Package

4

Contains DI Package

10810044960546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case