GUM®

Basic Information

• Brand Name: GUM®
• Primary DI: 00070942751469
• Version / Model: 800
• Catalog Number: CQA
• Company Name: SUNSTAR AMERICAS, INC.
• Labeler DUNS: 025066358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-08-29
• Public Version: 5
• Public Version Date: 2023-09-22
• Public Version Status: Update
• Public Device Record Key: d8efea4c-c5f6-45ce-8218-1a390094d1af

Device Description

RED-COTE® Plaque Disclosing Tablets

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJC	Plaque Disclosing Agent	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60408	Dental caries detecting stain	A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00070942751469	GS1
Package	10070942751466	GS1	Box	248	In Commercial Distribution
Unit of Use	80070942751465	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	10.4	Millimeter
Width	10.4	Millimeter
Depth	3.65	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit