Catalog Number

370-092

Brand Name

RUGBY

Version/Model Number

370-092

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

K896987,K896987,K896987,K896987

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

41866584-788b-4ac3-845a-bbd761261bd7

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Package DI Number

20305369995122

Quantity per Package

12

Contains DI Package

00305369995128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK