FDA.reportPublic FDA data

NC ROCKSTAR

Primary DI
06948546213444
Brand
NC ROCKSTAR
Company
Sino Medical Sciences Technology Inc.
Model
NCP-5.00-20-RX
Device description
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).
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222538000NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.2022-12-21LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948546213444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948546213444069485462134446948546213444

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic aligner auxiliary attachment kitA collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528191055
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948546214045SC HONKYTONKSCB-1.50-09-RX2023-08-04
06948546214052SC HONKYTONKSCB-1.50-15-RX2023-08-04
06948546214069SC HONKYTONKSCB-1.50-20-RX2023-08-04
06948546214076SC HONKYTONKSCB-2.00-09-RX2023-08-04
06948546214083SC HONKYTONKSCB-2.00-15-RX2023-08-04
06948546214090SC HONKYTONKSCB-2.00-20-RX2023-08-04
06948546214106SC HONKYTONKSCB-2.00-25-RX2023-08-04
06948546214113SC HONKYTONKSCB-2.25-09-RX2023-08-04
06948546214120SC HONKYTONKSCB-2.25-15-RX2023-08-04
06948546214137SC HONKYTONKSCB-2.25-20-RX2023-08-04
06948546214144SC HONKYTONKSCB-2.25-25-RX2023-08-04
06948546214151SC HONKYTONKSCB-2.25-30-RX2023-08-04
06948546214168SC HONKYTONKSCB-2.25-35-RX2023-08-04
06948546214175SC HONKYTONKSCB-2.50-09-RX2023-08-04
06948546214182SC HONKYTONKSCB-2.50-12-RX2023-08-04
06948546214199SC HONKYTONKSCB-2.50-15-RX2023-08-04
06948546214205SC HONKYTONKSCB-2.50-20-RX2023-08-04
06948546214212SC HONKYTONKSCB-2.50-25-RX2023-08-04
06948546214229SC HONKYTONKSCB-2.50-30-RX2023-08-04
06948546214236SC HONKYTONKSCB-2.50-35-RX2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610088FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
06971591769062Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769079Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769086Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769093Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769109Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769116Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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