Catalog Number

786300

Brand Name

Clear Advantage Male Continence Sheath

Version/Model Number

786300

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNX

Product Code Name

DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE

Public Device Record Key

cb10ae14-14f4-4491-a309-b6abe1106e30

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

10801741071819

Quantity per Package

5

Contains DI Package

00801741071812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA