Catalog Number

-

Brand Name

DISTRACTION, INTERNAL, STERILE

Version/Model Number

51-755-40-04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

PBJ

Product Code Name

Cranial Distraction System

Public Device Record Key

a055bc9e-1a2d-4a16-bca0-3fd311fd6d18

Public Version Date

April 21, 2021

Public Version Number

7

DI Record Publish Date

March 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-