Catalog Number

220-0104

Brand Name

OsteoMed

Version/Model Number

220-0104

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

MQN

Product Code Name

EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Public Device Record Key

1b65fdc1-2834-4175-966c-c7d38b2ec4c2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-