Catalog Number

51504

Brand Name

Aqua Lube

Version/Model Number

Natural Gel

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

0193298a-f4de-4e0b-81f1-b76c6c3ec98c

Public Version Date

December 06, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

10016169515047

Quantity per Package

6

Contains DI Package

20016169515044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON