NC ROCKSTAR

GUDID 06948546213383

The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

Sino Medical Sciences Technology Inc.

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic

• Primary Device ID: 06948546213383
• NIH Device Record Key: fdd62132-7234-4fb8-868b-740526248089
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC ROCKSTAR
• Version Model Number: NCP-4.50-12-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	06948546213383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222538

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: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [NC ROCKSTAR]

• 06948546213444: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213437: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213420: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213413: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213406: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213390: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213383: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213376: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213369: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213352: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213345: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213338: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213321: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213314: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213307: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213291: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213284: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213277: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213260: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213253: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213246: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213239: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213222: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213215: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213208: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213192: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213185: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213178: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213161: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213154: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213147: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213130: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213123: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213116: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213109: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213093: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213086: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213079: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213062: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213055: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213048: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213031: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213024: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath
• 06948546213017: The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon cath