UNIVERSAL UNIT MU-IT-Q

GUDID 07290110728144

TOOL

HI-TEC IMPLANTS LTD.

Dental implant/prosthesis surgical procedure kit

• Primary Device ID: 07290110728144
• NIH Device Record Key: 4f6591b3-d6cf-401e-95e7-cc6cc668b68e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL UNIT
• Version Model Number: MU-IT-Q
• Catalog Number: MU-IT-Q
• Company DUNS: 600710917
• Company Name: HI-TEC IMPLANTS LTD.
• 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: false
• 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	07290110728144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941575

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-14

On-Brand Devices [UNIVERSAL UNIT]

• 07290110728168: CAD CAM ABUTMENT
• 07290110728151: TOOL
• 07290110728144: TOOL
• 07290110728137: TOOL
• 07290110728120: ABUTMENT ANALOG
• 07290110728113: SLEEVE
• 07290110728106: TRANSFER
• 07290110728090: TRANSFER
• 07290110728083: FIXATION SCREW
• 07290110728076: FIXATION SCREW
• 07290110728069: SLEEVE
• 07290110728052: SLEEVE
• 07290110728045: HEALING CAP