BLACK MONOPOLAR SUCTION TUBE

GUDID B0992700554NS0

BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B0992700554NS0
• NIH Device Record Key: 2aa9298d-6b3e-43da-ad38-2db3c7422bcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLACK MONOPOLAR SUCTION TUBE
• Version Model Number: 2700-554NS
• 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

• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch
• Length: 5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896006218 [Primary]
HIBCC	B0992700554NS0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101080

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B0992700554NS0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992700554NS0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B0992700554NS0]

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: 2018-09-21
• Device Publish Date: 2018-08-21

On-Brand Devices [BLACK MONOPOLAR SUCTION TUBE]

• B0992700554NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED
• B0992700552NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED
• B0992700560NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED
• B0992700558NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED
• B0992700556NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED ANGLED
• B0992700550NS0: BLACK MONOPOLAR SUCTION TUBE INSULATED FLEXIBLE STRAIGHT