Catalog Number

-

Brand Name

Insert Osteo mat

Version/Model Number

04809815

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

JAK

Product Code Name

System, x-ray, tomography, computed

Public Device Record Key

b9921580-f7fd-4d2e-9fd3-c2c6ac3c4a26

Public Version Date

November 17, 2021

Public Version Number

4

DI Record Publish Date

July 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-