Catalog Number

51004

Brand Name

Aqua Lube

Version/Model Number

Regular

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

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

f25800b0-eec1-402c-b5ea-e128e8bfe0ec

Public Version Date

August 07, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

20016169510049

Quantity per Package

6

Contains DI Package

00016169510045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHRINK WRAP