Catalog Number

-

Brand Name

Dynex

Version/Model Number

DS-HP60-200-45B

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

K202054

Product Code

JDW

Product Code Name

Pin, Fixation, Threaded

Public Device Record Key

81b08f0d-5234-4c2d-b796-e76e122af4fe

Public Version Date

September 21, 2021

Public Version Number

1

DI Record Publish Date

September 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-