Catalog Number

1067495

Brand Name

Hygienic Sheaths

Version/Model Number

Hygienic Sheaths

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

-

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

cb73ada5-8934-4d7b-999f-cb6d2960fc9d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

60889971067494

Quantity per Package

10

Contains DI Package

40889971067490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case