Catalog Number

-

Brand Name

EQUATE

Version/Model Number

4048645

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

673c1b35-8732-4f05-b3cf-b58ff3f5108e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

50681131297771

Quantity per Package

24

Contains DI Package

00681131297776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case