INSULATED METAL HANDLE

GUDID B09929010640

INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & HIGH FREQUENCY CONNECTOR

SONTEC INSTRUMENTS, INC.

Laparoscopic surgical procedure kit, non-medicated, reusable

• Primary Device ID: B09929010640
• NIH Device Record Key: 537e5d95-9f16-4e3c-9fe3-48ab8305ae7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSULATED METAL HANDLE
• Version Model Number: 2901-064
• 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
• 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
• 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
• 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 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 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007321 [Primary]
HIBCC	B09929010640 [Previous]

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

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09929010640]

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: 2018-09-24
• Device Publish Date: 2018-08-22

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