Catalog Number

217-1215

Brand Name

OsteoMed

Version/Model Number

217-1215

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

PBJ

Product Code Name

Cranial Distraction System

Public Device Record Key

5a94a4ea-914d-4a25-91d5-d46f0e0ffc43

Public Version Date

September 23, 2019

Public Version Number

3

DI Record Publish Date

April 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-