KY Touch 2-in-1 Massage Creme & Pleasure Gel - Personal Lubricant - RB Health (us) LLC

Duns Number:081049410

Device Description: Personal Lubricant

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More Product Details

Catalog Number

-

Brand Name

KY Touch 2-in-1 Massage Creme & Pleasure Gel

Version/Model Number

Personal Lubricant

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, personal

Device Record Status

Public Device Record Key

1a2a1c22-a669-4989-8313-5e94fd52b6ca

Public Version Date

December 13, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10067981962168

Quantity per Package

4

Contains DI Package

00067981962161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"RB HEALTH (US) LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24