INSULATED METAL HANDLE

GUDID 00192896100534

INSULATED METAL HANDLE ANGLED ROTATING HEAD FOR 3 MILLIMETER,5 MILLIMETER,10 MILLIMETER TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Laparoscopic surgery handle

• Primary Device ID: 00192896100534
• NIH Device Record Key: b42d1d5d-d53e-409f-bc71-2d12ef0b3f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSULATED METAL HANDLE
• Version Model Number: 2901-060
• 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: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896100534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102921

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896100534]

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: 2020-03-03
• Device Publish Date: 2020-02-24

On-Brand Devices [INSULATED METAL HANDLE]

• B09929010640: INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & HIGH FREQUENCY CONNECTOR
• B09929010620: INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & RATCHET
• B09929010600: INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD
• 00192896100534: INSULATED METAL HANDLE ANGLED ROTATING HEAD FOR 3 MILLIMETER,5 MILLIMETER,10 MILLIMETER TUBE SHA