Tunneler

GUDID 00192896112087

Tunneler 1.5 Inch Handle Straight Shaft

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable Vascular dilator, reusable

• Primary Device ID: 00192896112087
• NIH Device Record Key: 297325cc-31e8-4ddb-a564-57d48ae32853
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tunneler
• Version Model Number: 2700-101
• 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
• 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: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch
• Length: 20 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896112087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100518

FDA Product Code

• DWP: DILATOR, VESSEL, SURGICAL

Sterilization

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

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896112087]

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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Tunneler]

• B09927001000: TUNNELER
• 00192896112087: Tunneler 1.5 Inch Handle Straight Shaft