Evobite Flat Trays

GUDID 00817610025503

Evobite Flat Trays - Individual Tray

GOOD FIT TECHNOLOGIES, LLC

Dental impression tray, single-use

• Primary Device ID: 00817610025503
• NIH Device Record Key: 08ed0689-5595-4158-975c-0ce0bf568c24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evobite Flat Trays
• Version Model Number: 817610025503
• Company DUNS: 080341158
• Company Name: GOOD FIT TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817610025503 [Primary]

FDA Product Code

• EHY: Tray, Impression, Preformed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-17
• Device Publish Date: 2019-10-09

Devices Manufactured by GOOD FIT TECHNOLOGIES, LLC

• 00817610025190 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - S1 - A3
• 00817610025206 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - M1 - A3
• 00817610025213 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - M2 - A3
• 00817610025220 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - L1 - A3
• 00817610025237 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - L2 - A3
• 00817610025244 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Upper - L3 - A3
• 00817610025251 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Lower - S1 - A3
• 00817610025268 - Good Fit Instant Overdentures: 2019-12-25 Good Fit Instant Overdentures - Arch - Lower - M1 - A3