SC HONKYTONK

GUDID 06948546214472

The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Sino Medical Sciences Technology Inc.

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• Primary Device ID: 06948546214472
• NIH Device Record Key: a8e869ab-0d33-46e5-a617-4c4555a56d5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SC HONKYTONK
• Version Model Number: SCB-4.00-15-RX
• Company DUNS: 528191055
• Company Name: Sino Medical Sciences Technology 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948546214472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223022

FDA Product Code

• LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [SC HONKYTONK]

• 06948546214519: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214502: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214496: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214489: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214472: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214465: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214458: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214441: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214434: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214427: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214410: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214403: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214397: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214380: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214373: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214366: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214359: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214342: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214335: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214328: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214311: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214304: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214298: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214281: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214274: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214267: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214250: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214243: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214236: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214229: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214212: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214205: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214199: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214182: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214175: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214168: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214151: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214144: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214137: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214120: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214113: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214106: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214090: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214083: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214076: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214069: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214052: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilat
• 06948546214045: The SC HONKYTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatati