DISPOSABLE HANDSWITCH SUCTION COAGULATOR SCH12

GUDID 00192896009479

DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE

SONTEC INSTRUMENTS, INC.

Surgical power tool hand-switch

• Primary Device ID: 00192896009479
• NIH Device Record Key: 72de5723-fd5f-48a6-bc73-4c90193a9da7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE HANDSWITCH SUCTION COAGULATOR
• Version Model Number: SCH12
• Catalog Number: SCH12
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896009479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033003

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00192896009479]

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: 2018-09-17
• Device Publish Date: 2018-08-16

On-Brand Devices [DISPOSABLE HANDSWITCH SUCTION COAGULATOR]

• 00192896009479: DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE
• 00192896009462: DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE