Catalog Number

5942644

Brand Name

CS 7600 Hygienic Sheath

Version/Model Number

CS 7600 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)

Yes

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

659aee80-e947-4617-b84c-b9782b2fd326

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Package DI Number

60192155942648

Quantity per Package

20

Contains DI Package

40192155942644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS