Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS7701B-4

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)

-

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

0fe8c05c-472d-4c79-8591-fbdeac3a6588

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 13, 2017

Package DI Number

10849027002201

Quantity per Package

80

Contains DI Package

00849027002204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case