Catalog Number

-

Brand Name

hcs

Version/Model Number

HCS3013

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

5dc37bd2-da5c-44ce-846f-93446298e2d5

Public Version Date

September 02, 2020

Public Version Number

3

DI Record Publish Date

December 31, 2019

Package DI Number

10849027001242

Quantity per Package

6

Contains DI Package

00849027001245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case