Catalog Number

92332

Brand Name

Reality

Version/Model Number

Ultra Textured

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

b6d158f1-fa9b-4e01-aad1-32a46589570b

Public Version Date

December 06, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10019283923323

Quantity per Package

8

Contains DI Package

20019283923320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON