Catalog Number

200500

Brand Name

Liquid Lubricant

Version/Model Number

5 mL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211998,K211998

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

c7032e51-4041-4f97-b0b0-ba3880103754

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

30850014621774

Quantity per Package

900

Contains DI Package

00850014621773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case