THORACOSCOPIC COMPLETE SET 1 20906-1526

GUDID 00192896092396

THORACOSCOPIC COMPLETE SET 1

SONTEC INSTRUMENTS, INC.

General surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00192896092396
• NIH Device Record Key: fbe7ea6d-1630-4e52-8f59-95d979668fd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THORACOSCOPIC COMPLETE SET 1
• Version Model Number: 20906-1526
• Catalog Number: 20906-1526
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896092396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896092396]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-21
• Device Publish Date: 2019-05-13

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)