Catalog Number

57-05

Brand Name

AQUAGEL

Version/Model Number

LUBRICATING GEL

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

K864556,K864556,K864556

Product Code

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

bed7b017-9660-4692-8edf-b6ba6533364d

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

December 19, 2016

Package DI Number

20855683006368

Quantity per Package

6

Contains DI Package

10855683006361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX