Catalog Number

-

Brand Name

Stratum RS

Version/Model Number

STRM-MDS-2422RS-ST

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

K200785

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

1b6cf87d-88d2-419d-8328-0af96f2d48d9

Public Version Date

September 23, 2022

Public Version Number

2

DI Record Publish Date

November 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-