GingiTrac

GUDID 00817051021232

GingiTrac Minimix Refill retraction paste, 48

CENTRIX, INC.

Gingival retraction cord, non-medicated

• Primary Device ID: 00817051021232
• NIH Device Record Key: 8faf847f-bd3d-4145-8680-4b258a1f8126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GingiTrac
• Version Model Number: 360069
• Company DUNS: 053707303
• Company Name: CENTRIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051021232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952728

FDA Product Code

• MVL: Cord, Retraction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [GingiTrac]

• 00817051021270: GingiTrac Introduction retraction paste kit
• 00817051021263: GingiTrac Plus retraction paste Kit
• 00817051021256: GingiTrac Standard retraction paste Kit
• 00817051021249: GingiTrac 50ml retraction paste cartridge, 2
• 00817051021232: GingiTrac Minimix Refill retraction paste, 48
• 00817051021225: GingiTrac Minimix Starter retraction paste Kit