DARDIK DEBAKEY VASCULAR CLAMP 2100-511

GUDID 00192896093775

DARDIK DEBAKEY VASCULAR CLAMP

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable

• Primary Device ID: 00192896093775
• NIH Device Record Key: f3f5f3cf-1621-4025-8c51-3e79613b0e22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DARDIK DEBAKEY VASCULAR CLAMP
• Version Model Number: 2100-511
• Catalog Number: 2100-511
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch
• Length: 6.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896093775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092544

FDA Product Code

• DXC: CLAMP, VASCULAR

Sterilization

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

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896093775]

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: 2019-08-21
• Device Publish Date: 2019-03-07

On-Brand Devices [DARDIK DEBAKEY VASCULAR CLAMP]

• B09921005110: DARDIK DEBAKEY VASCULAR CLAMP
• 00192896093775: DARDIK DEBAKEY VASCULAR CLAMP