Catalog Number

DS-100

Brand Name

DS-100 ORI Drop Stop Kit

Version/Model Number

DS-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

f3a6d533-f5b2-4e3a-b5d7-e5f794b2b721

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

March 02, 2017

Package DI Number

00854150007125

Quantity per Package

40

Contains DI Package

00854150007118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case