Catalog Number

-

Brand Name

OS2®-VP

Version/Model Number

T40 SP190

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

K153770

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

bcbe1854-aa1b-4b13-8886-4375404d29a9

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-