Catalog Number

401774TS

Brand Name

NA

Version/Model Number

401.774TS

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

K953644,K063049,K102694,K112583

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

73b7a0b0-750e-4f04-bdc4-b8aca4a87292

Public Version Date

May 02, 2022

Public Version Number

4

DI Record Publish Date

March 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-