Catalog Number

-

Brand Name

Atlas Colors Case

Version/Model Number

10100C

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

38e947ff-21d3-4cbd-b953-c4f76ff9362a

Public Version Date

September 16, 2019

Public Version Number

1

DI Record Publish Date

September 08, 2019

Package DI Number

00726893111165

Quantity per Package

12

Contains DI Package

20726893111169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box of 12 pieces