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.

• 00192896122031 - Ceramitec Universal Klick Rongeur Handle: 2025-09-02 Ceramitec Universal Handle For Turnable Klick Rongeur
• 00192896122000 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors 45 Degrees Squeeze Handle
• 00192896122017 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors 90 Degrees Squeeze Handle
• 00192896122024 - Heartline Potts Vascular Scissors: 2025-08-19 Heartline Potts Vascular Scissors Miniature 125 Degrees Squeeze Handle
• 00192896121959 - Heartline Atrial Ball Lock: 2025-08-18 Heartline Atrial Ball Lock
• 00192896121966 - Heartline Crilewood Needle Holder: 2025-08-18 Heartline Crilewood Needle Holder With Lock Straight Tungsten Carbide Jaw Squeeze Handle
• 00192896121973 - Heartline Ryder Needle Holder: 2025-08-18 Heartline Ryder Needle Holder With Lock Tungsten Carbide Jaw Squeeze Handle
• 00192896121980 - Heartline Gemini Dissection Forceps: 2025-08-18 Heartline Gemini Dissection Forceps Spreading Jaw