Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS5007

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

-

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

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

64453540-4939-461a-adc9-5a0afb724c96

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 17, 2017

Package DI Number

10849027000153

Quantity per Package

4

Contains DI Package

00849027000156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case