TUBBS MITRAL VALVE DILATOR

GUDID B09927001200

TUBBS MITRAL VALVE DILATOR

SONTEC INSTRUMENTS, INC.

Mitral valve dilator

• Primary Device ID: B09927001200
• NIH Device Record Key: 1299e946-2a52-4584-b66a-e3b110be8c8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TUBBS MITRAL VALVE DILATOR
• Version Model Number: 2700-120
• 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: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896010727 [Primary]
HIBCC	B09927001200 [Previous]

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

[B09927001200]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927001200]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927001200]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-24

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