DEBAKEY CLAMP INSERT

GUDID B0992901249S0

DEBAKEY CLAMP DOUBLE-ACTION JAWS FOR TUBE SHAFT

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: B0992901249S0
• NIH Device Record Key: a8e53b9d-4073-4a73-9a48-eee9c04c4dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEBAKEY CLAMP INSERT
• Version Model Number: 2901-249S
• 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: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter
• Length: 330 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007642 [Primary]
HIBCC	B0992901249S0 [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

[B0992901249S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992901249S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992901249S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-08
• Device Publish Date: 2018-08-22

On-Brand Devices [DEBAKEY CLAMP INSERT]

• B0992901273S0: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901249S0: DEBAKEY CLAMP DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B0992901274S0: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901274L0: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B09929012740: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901273L0: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B09929012730: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901272S0: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901272L0: DEBAKEY CLAMP DOUBLE TEETH LENGTH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B09929012720: DEBAKEY CLAMP DOUBLE TEETH DOUBLE-ACTION JAW FOR TUBE SHAFT
• B0992901249L0: DEBAKEY CLAMP DOUBLE-ACTION JAWS FOR TUBE SHAFT
• B09929012490: DEBAKEY CLAMP DOUBLE-ACTION JAWS FOR TUBE SHAFT