MYOCARDIAL DILATOR

GUDID B09927002520

MYOCARDIAL DILATOR GRADUATED

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable Vascular dilator, reusable

• Primary Device ID: B09927002520
• NIH Device Record Key: aeea9589-aa97-4020-ad52-cc4085f05161
• Commercial Distribution Discontinuation: 2018-06-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MYOCARDIAL DILATOR
• Version Model Number: 2700-252
• 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

Device Dimensions

• Length: 6 Inch
• Outer Diameter: 12.5 Centimeter
• Length: 6 Inch
• Outer Diameter: 12.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B09927002520 [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

[B09927002520]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09927002520]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

On-Brand Devices [MYOCARDIAL DILATOR ]

• B09927002500: MYOCARDIAL DILATOR GRADUATED
• B09927002520: MYOCARDIAL DILATOR GRADUATED