JO All-In-One Massage Glide - Fragrance Free - Massage 1 floz / 30 mL - silicone-based massage glide - CC Wellness LLC

Duns Number:067692292

Device Description: silicone-based massage glide

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More Product Details

Catalog Number

-

Brand Name

JO All-In-One Massage Glide - Fragrance Free - Massage 1 floz / 30 mL

Version/Model Number

10145

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

K180083,K180083

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

f05798b0-8de1-41c2-9bfa-1fcce25e056d

Public Version Date

September 16, 2022

Public Version Number

1

DI Record Publish Date

September 08, 2022

Additional Identifiers

Package DI Number

10796494000134

Quantity per Package

24

Contains DI Package

00796494000137

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