Catalog Number

0103-0500

Brand Name

HipCheck

Version/Model Number

01030500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FQO

Product Code Name

TABLE, OPERATING-ROOM, AC-POWERED

Public Device Record Key

28a88c07-7066-4cf4-8e4c-8ae393ef8ce9

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

January 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-