Champ

GUDID 00817051020006

Champ Pit & Fissure Sealant, 16 pk

CENTRIX, INC.

Dental pit/fissure sealant

• Primary Device ID: 00817051020006
• NIH Device Record Key: 4f3c5172-a0ca-4795-a31a-c2dc497ce4e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Champ
• Version Model Number: 360116
• 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	00817051020006 [Primary]

FDA Product Code

• EBD: Coating, Filling Material, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Champ]

• 00817051020341: Champ Pit & Fissure Sealant, 64 pk
• 00817051020006: Champ Pit & Fissure Sealant, 16 pk