Lubelife - Cotton Candy - 8oz / 240 mL - International - 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

Lubelife - Cotton Candy - 8oz / 240 mL - International

Version/Model Number

40792-INT

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

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

0ca2160f-1419-4f5e-a42b-a96788c3c89e

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Additional Identifiers

Package DI Number

10796494001384

Quantity per Package

72

Contains DI Package

00796494001387

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