Catalog Number

-

Brand Name

Probe Silky Light lubricant - 8.5fl oz/250ml

Version/Model Number

000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K952465,K952465

Product Code

HIS

Product Code Name

Condom

Public Device Record Key

923a59a0-e12f-4003-adb7-92838ed78a20

Public Version Date

May 21, 2021

Public Version Number

7

DI Record Publish Date

October 26, 2016

Package DI Number

B25095

Quantity per Package

12

Contains DI Package

B25005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard carton