JO Gelato Creme Brulee 1oz/30ml - Water-based Personal Lubricant - CC Wellness LLC

Duns Number:067692292

Device Description: Water-based Personal Lubricant

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More Product Details

Catalog Number

-

Brand Name

JO Gelato Creme Brulee 1oz/30ml

Version/Model Number

41020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

-

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

1c9d5ba8-5381-4eb7-9606-c4997282e5e7

Public Version Date

September 09, 2022

Public Version Number

8

DI Record Publish Date

May 21, 2018

Additional Identifiers

Package DI Number

B362410201

Quantity per Package

12

Contains DI Package

B362410200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CC WELLNESS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 199