MICTEC HOOK ELECTRODE

GUDID B09920945010

MICTEC HOOK ELECTRODE CURVED UPWARD

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: B09920945010
• NIH Device Record Key: 167a541a-dd4c-4f81-91c8-e51bd0ecb521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICTEC HOOK ELECTRODE
• Version Model Number: 20945-01
• 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: false
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896008892 [Primary]
HIBCC	B09920945010 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B09920945010]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09920945010]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09920945010]

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: 2018-09-24
• Device Publish Date: 2018-08-24

On-Brand Devices [MICTEC HOOK ELECTRODE ]

• B09920945040: MICTEC HOOK ELECTRODE HOOK CURVED RIGHT CURVED UPWARD
• B09920945030: MICTEC HOOK ELECTRODE CURVED UPWARD CURVED LEFT
• B09920945010: MICTEC HOOK ELECTRODE CURVED UPWARD
• 00192896111431: Mictec Hook Electrode Insulated 30 Degree Curved Up