Mitchell Aortic Valve Dilator

GUDID 00192896104785

Mitchell Aortic Valve Dilator

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable

• Primary Device ID: 00192896104785
• NIH Device Record Key: 2d040136-1da6-481b-b80a-4ded17f1f25b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mitchell Aortic Valve Dilator
• Version Model Number: 2700-215
• 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

• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch
• Device Size Text, specify: 0
• Length: 9 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896104785 [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

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896104785]

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: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [Mitchell Aortic Valve Dilator]

• B09927002300: MITCHELL AORTIC VALVE DILATOR SET OF 24
• B09927002250: MITCHELL AORTIC VALVE DILATOR
• B09927002240: MITCHELL AORTIC VALVE DILATOR
• B09927002230: MITCHELL AORTIC VALVE DILATOR
• B09927002220: MITCHELL AORTIC VALVE DILATOR
• B09927002210: MITCHELL AORTIC VALVE DILATOR
• B09927002200: MITCHELL AORTIC VALVE DILATOR
• B09927002190: MITCHELL AORTIC VALVE DILATOR
• B09927002180: MITCHELL AORTIC VALVE DILATOR
• B09927002170: MITCHELL AORTIC VALVE DILATOR
• B09927002160: MITCHELL AORTIC VALVE DILATOR
• B09927002150: MITCHELL AORTIC VALVE DILATOR
• B09927002140: MITCHELL AORTIC VALVE DILATOR
• B09927002130: MITCHELL AORTIC VALVE DILATOR
• B09927002120: MITCHELL AORTIC VALVE DILATOR
• B09927002110: MITCHELL AORTIC VALVE DILATOR
• B09927002100: MITCHELL AORTIC VALVE DILATOR
• B09927002090: MITCHELL AORTIC VALVE DILATOR
• B09927002080: MITCHELL AORTIC VALVE DILATOR
• B09927002070: MITCHELL AORTIC VALVE DILATOR
• B09927002060: MITCHELL AORTIC VALVE DILATOR
• B09927002050: MITCHELL AORTIC VALVE DILATOR
• B09927002040: MITCHELL AORTIC VALVE DILATOR
• B09927002030: MITCHELL AORTIC VALVE DILATOR
• B09927002020: MITCHELL AORTIC VALVE DILATOR
• 00192896104785: Mitchell Aortic Valve Dilator
• 00192896104778: Mitchell Aortic Valve Dilator
• 00192896104761: Mitchell Aortic Valve Dilator
• 00192896104754: Mitchell Aortic Valve Dilator
• 00192896104747: Mitchell Aortic Valve Dilator