MODULAR SYSTEM G-HC

GUDID 07290110728458

CAP

HI-TEC IMPLANTS LTD.

Dental implant system

• Primary Device ID: 07290110728458
• NIH Device Record Key: a8f4a846-6b3d-44c1-8583-8d4dd378ca85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODULAR SYSTEM
• Version Model Number: G-HC
• Catalog Number: G-HC
• 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	07290110728458 [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 [MODULAR SYSTEM ]

• 07290110728496: SLEEVE
• 07290110728489: SLEEVE
• 07290110728472: ABUTMENT ANALOG
• 07290110728465: TRANSFER
• 07290110728458: CAP