Good Fit Instant Custom Trays

GUDID 00817610023400

Good Fit Instant Custom Trays - Lower - M

GOOD FIT TECHNOLOGIES, LLC

Dental impression tray, single-use

• Primary Device ID: 00817610023400
• NIH Device Record Key: 10e1ec24-52f0-42c3-9899-f1a5d693fdf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Good Fit Instant Custom Trays
• Version Model Number: 817610023400
• 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	00817610023400 [Primary]

FDA Product Code

• EHY: Tray, Impression, Preformed

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: 2017-01-10

On-Brand Devices [Good Fit Instant Custom Trays]

• 00817610023424: Good Fit Instant Custom Trays - Lower - XL
• 00817610023417: Good Fit Instant Custom Trays - Lower - L
• 00817610023400: Good Fit Instant Custom Trays - Lower - M
• 00817610023394: Good Fit Instant Custom Trays - Lower - S
• 00817610023387: Good Fit Instant Custom Trays - Upper - XL
• 00817610023370: Good Fit Instant Custom Trays - Upper - L
• 00817610023363: Good Fit Instant Custom Trays - Upper - M
• 00817610023356: Good Fit Instant Custom Trays - Upper - S