Catalog Number

5475-08-E

Brand Name

Innomed, Inc.

Version/Model Number

5475-08-E

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

HWM

Product Code Name

Osteotome

Public Device Record Key

301185a0-8392-4453-919f-3dbf1bee6ffd

Public Version Date

February 13, 2020

Public Version Number

1

DI Record Publish Date

February 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-