Catalog Number

610-025

Brand Name

System Drape

Version/Model Number

610-025

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

K943393,K943393

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

be1cc2cc-45e4-4cfb-8c59-2b9f65ccbea8

Public Version Date

September 03, 2021

Public Version Number

4

DI Record Publish Date

August 22, 2017

Package DI Number

00841436101417

Quantity per Package

24

Contains DI Package

10841436101414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-