AccessGUDID - DEVICE: Repair-It (00010705400913)

GUDID

Device Identifier (DI) Information

Brand Name: Repair-It
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAJESTIC DRUG CO. INC.

Primary DI Number: 00010705400913
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001496777 *Terms of Use

Device Description: Repair-It Advanced Denture Repair Kit repairs broken dentures and denture teeth in minutes: Fix breaks, replace loose teeth, and mend cracks.

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":	No
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?
31787	Denture repair kit, home-use	A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBO	Over The Counter Denture Repair Kit

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: f16881eb-9b42-40d3-bfbc-298ca91a4738
Public Version Date: November 06, 2020
Public Version Number: 3
DI Record Publish Date: July 27, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20010705400917	16	70010705400912	In Commercial Distribution	Case
70010705400912	6	00010705400913	In Commercial Distribution	Pack
30010705400914	16	70010705400912	In Commercial Distribution	Case