Catalog Number

723-946

Brand Name

Streamline TL Spinal Fixation System

Version/Model Number

723-946

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

-

Product Code

HXX

Product Code Name

SCREWDRIVER

Public Device Record Key

10060c6f-8eea-4059-ac1a-79226ae37282

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

September 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-