Catalog Number

5942529

Brand Name

Hygienic Sheath

Version/Model Number

Hygienic Sheath

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

02f9d997-4efd-4b8b-9651-d8a9440b0cea

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Package DI Number

60192155942525

Quantity per Package

10

Contains DI Package

40192155942521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-