Catalog Number

-

Brand Name

One Degree Medical

Version/Model Number

ODM-1100

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"

Yes

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

1e0e26b9-ca16-4a44-bd97-131d03a9ce53

Public Version Date

June 23, 2020

Public Version Number

1

DI Record Publish Date

June 15, 2020

Package DI Number

10860003583019

Quantity per Package

24

Contains DI Package

00860003583012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case