AccessGUDID - DEVICE: EFFERGRIP ADHESIVE 1.5OZ TUBE 24 (00814832010300)

GUDID

Device Identifier (DI) Information

Brand Name: EFFERGRIP ADHESIVE 1.5OZ TUBE 24
Version or Model: 10814832010307
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medtech Products Inc.

Primary DI Number: 00814832010300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060272465 *Terms of Use

Device Description: EFFERGRIP ADHESIVE 1.5OZ TUBE 24

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46125	Carboxymethylcellulose sodium denture adhesive	An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a008e873-365e-4367-a167-0980570dfd1b
Public Version Date: June 26, 2025
Public Version Number: 3
DI Record Publish Date: October 07, 2022