Catalog Number

B33143600-01

Brand Name

UNiD OCT

Version/Model Number

B33143600-01

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

NKG

Product Code Name

Orthosis, Cervical Pedicle Screw Spinal Fixation

Public Device Record Key

126d4b9c-0f9d-4dc8-9f8e-46fe1f29e900

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

August 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-