Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS0211

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)

-

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

2f123481-702c-4341-905e-2bc6ad75f49a

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 31, 2021

Package DI Number

30849027004858

Quantity per Package

144

Contains DI Package

00849027004857

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner box