Catalog Number

-

Brand Name

Streamline® OCT Occipito-Cervico-Thoracic System

Version/Model Number

23-35-AWL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 28, 2017

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

HWJ

Product Code Name

AWL

Public Device Record Key

1b013d33-9205-42b7-ae41-ad5751fa743d

Public Version Date

October 14, 2021

Public Version Number

3

DI Record Publish Date

September 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-