Catalog Number

-

Brand Name

Trojan Willa Lubricant

Version/Model Number

00022600999379

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

K141034

Product Code

NUC

Product Code Name

Lubricant, personal

Public Device Record Key

f39d7d33-5c9d-402b-b489-2426dc0ad703

Public Version Date

October 27, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-