Catalog Number

HPS-HB02

Brand Name

HIP PRESERVATION SYSTEM SIGNATURE SERIES

Version/Model Number

HPS-HB02

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

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

GFF

Product Code Name

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

24688d46-a06a-4b2b-8435-a1fc1c3101d3

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

October 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-