Catalog Number

-

Brand Name

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Version/Model Number

03.65.754

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2020

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

K193083

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

74a119a7-a64a-4419-8599-c2085efb322f

Public Version Date

July 31, 2020

Public Version Number

1

DI Record Publish Date

July 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-