Catalog Number

B33143600-17

Brand Name

UNiD_PASS

Version/Model Number

B33143600-17

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2021

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

K153169

Product Code

NKG

Product Code Name

Orthosis, Cervical Pedicle Screw Spinal Fixation

Public Device Record Key

ad7df508-3c81-49b3-9c28-174e0c09154b

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

August 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-