Catalog Number

-

Brand Name

traxi® Panniculus Retractor Extender

Version/Model Number

PRS-1050

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)

Yes

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

99e85103-bd4a-4425-9dab-a497696fbac5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

20814247020363

Quantity per Package

5

Contains DI Package

10814247020366

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-