GluGone Adhesive Remover, 0.67 oz. - 0.67 OZ - CHEMENCE MEDICAL PRODUCTS, INC.

Duns Number:079163089

Device Description: 0.67 OZ

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More Product Details

Catalog Number

GG80148

Brand Name

GluGone Adhesive Remover, 0.67 oz.

Version/Model Number

GG80148

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

KOX

Product Code Name

Solvent, Adhesive Tape

Device Record Status

Public Device Record Key

9cf02d49-2716-43bb-998e-069c1398c9b8

Public Version Date

July 05, 2022

Public Version Number

1

DI Record Publish Date

June 27, 2022

Additional Identifiers

Package DI Number

10854137001730

Quantity per Package

48

Contains DI Package

00854137001733

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CHEMENCE MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 11