EFFERGRIP ADHESIVE 1.5OZ TUBE 24 - EFFERGRIP ADHESIVE 1.5OZ TUBE 24 - MEDTECH PRODUCTS INC.

Duns Number:060272465

Device Description: EFFERGRIP ADHESIVE 1.5OZ TUBE 24

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More Product Details

Catalog Number

-

Brand Name

EFFERGRIP ADHESIVE 1.5OZ TUBE 24

Version/Model Number

10814832010307

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"

Yes

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

KOL

Product Code Name

Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

Device Record Status

Public Device Record Key

a008e873-365e-4367-a167-0980570dfd1b

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Additional Identifiers

Package DI Number

10814832010307

Quantity per Package

1

Contains DI Package

00814832010300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single

"MEDTECH 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. 6
U Unclassified 14