I-VIEW Z-765.22.000

GUDID 00192896071865

I-VIEW FOR PROFESSIONAL HEADBAND

SONTEC INSTRUMENTS, INC.

Loupe

• Primary Device ID: 00192896071865
• NIH Device Record Key: c9658a5f-1a97-40d1-934d-386fee752a64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-VIEW
• Version Model Number: Z-765.22.000
• Catalog Number: Z-765.22.000
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, 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: false
• 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: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896071865 [Primary]

FDA Product Code

• FSP: LOUPE, DIAGNOSTIC/SURGICAL

Sterilization

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

[00192896071865]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-12

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896121003 - Kerrison Rongeur: 2025-01-14 Kerrison Rongeur With Ejector Pin Silicone Handle Internal Spring 14 Millimeter Opening 40 Degree Forward Thin Footplate
• 00192896121010 - Ferris-Smith Rongeur: 2025-01-14 Ferris-Smith Rongeur Take Apart With Internal Spring Straight 3 Millimeter x 10 Millimeter
• 00192896121027 - Ferris-Smith Rongeur: 2025-01-14 Ferris-Smith Rongeur Take Apart With Internal Spring Straight 4 Millimeter x 13 Millimeter
• 00192896121034 - Lemmon Sternal Spreader: 2025-01-14 Lemmon Sternal Spreader Serrated
• 00192896120952 - Metzenbaum Scissors: 2024-12-31 Metzenbaum Scissors Classic Curved Blade Fine
• 00192896120969 - Derf Needle Holder: 2024-12-31 Derf Needle Holder Tungsten Carbide Serrated Titanium
• 00192896120792 - Classic Dental Elevator Set: 2024-11-25 Classic Dental Elevator Set With Tray (8 Each)
• 00192896120808 - Dental Set: 2024-11-25 Dental Burnisher/Curette/Probe/Scaler Set Without Tray (13 Each)