Gishy Goo 500006

GUDID 00883205107275

Gishy Goo! One-Patient Kit Tooth Color

ULTRADENT PRODUCTS, INC.

Orthodontic appliance system, adjustable

• Primary Device ID: 00883205107275
• NIH Device Record Key: 937b8400-22d8-47d9-b1a2-eb463e6d8841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gishy Goo
• Version Model Number: 500006
• Catalog Number: 500006
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: false
• 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: true

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205107275 [Primary]

FDA Product Code

• EGD: WAX, DENTAL, INTRAORAL

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: 2018-06-18
• Device Publish Date: 2018-05-17

On-Brand Devices [Gishy Goo]

• 00883205107596: Gishy Goo! Trial Syringe
• 00883205107312: Gishy Goo! Syringe, Tooth Color 10-Pack
• 00883205107282: Gishy Goo! One-Patient Kit Tooth Color 10-Pack
• 00883205107275: Gishy Goo! One-Patient Kit Tooth Color
• 00883205106537: Gishy Goo! Tooth Color Refill 50 pk
• 00883205031860: Gishy Goo! One-Patient Kit Tooth Color