OrthoFX

GUDID 18600033217445

ORTHOFX

Dental impression material kit, single-use

• Primary Device ID: 18600033217445
• NIH Device Record Key: 512fc34f-56a1-42f0-8588-72809c24f95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoFX
• Version Model Number: HIK1
• Company DUNS: 033755180
• Company Name: ORTHOFX
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 4159360006
• Email: support@care.orthofx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	18600033217445 [Primary]

FDA Product Code

• ELW: Material, Impression

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: 2020-05-04
• Device Publish Date: 2020-04-24

On-Brand Devices [OrthoFX]

• 18600033217131: ZR1
• 18600033217377: TBR1
• 18600033217063: Z1
• 18600033217445: HIK1
• 00860003321706: Updated UDI submission for Zendura material aligners.
• 00860003321737: OrthoFX Retainer
• 00860003321713: OrthoFX Retainer
• 00086000332174: Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00860003321765: Tetra Bright Aligners Tetra Bright Aligners appears to whiten teeth while correcting dentition.
• 00860003321775: Boil and Bite Home Impression Kit.