Catalog Number

8572D

Brand Name

HYPERFLEX

Version/Model Number

8572D

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Public Device Record Key

eca4c543-5fc0-453b-8715-d042ad91894a

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 13, 2020

Package DI Number

20845854041625

Quantity per Package

5

Contains DI Package

10845854041628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON