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 Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle 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