Home GUDID 06934955942020 Sapphire II Pro
Primary DI 06934955942020
Brand Sapphire II Pro
Company OrbusNeich Medical (ShenZhen) Co., Ltd.
Model 210-083-5UU
Device description Balloon Dilatation Catheter
Published 2018-03-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LIT Catheter, Angioplasty, Peripheral, Transluminal LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2 LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06934955942020 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06934955942020 06934955942020 6934955942020
GMDN Terms# Term, Definition table Term Definition Coronary angioplasty balloon catheter, basic A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 8 Millimeter Outer Diameter 1 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry, dark, cool place.
Regulatory Flags# DUNS number 530923226 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07640142570509 OPN NC SIS Medical AG LOX 2022-12-12 07640142570516 OPN NC SIS Medical AG LOX 2022-12-12 07640142570523 OPN NC SIS Medical AG LOX 2022-12-12 07640142570530 OPN NC SIS Medical AG LOX 2022-12-12 07640142570547 OPN NC SIS Medical AG LOX 2022-12-12 07640142570554 OPN NC SIS Medical AG LOX 2022-12-12 07640142570561 OPN NC SIS Medical AG LOX 2022-12-12 07640142570578 OPN NC SIS Medical AG LOX 2022-12-12 07640142570585 OPN NC SIS Medical AG LOX 2022-12-12 07640142570592 OPN NC SIS Medical AG LOX 2022-12-12 07640142570608 OPN NC SIS Medical AG LOX 2022-12-12 07640142570615 OPN NC SIS Medical AG LOX 2022-12-12 07640142570622 OPN NC SIS Medical AG LOX 2022-12-12 07640142570639 OPN NC SIS Medical AG LOX 2022-12-12 07640142570646 OPN NC SIS Medical AG LOX 2022-12-12 07640142572855 OPN NC SIS Medical AG LOX 2022-12-12 07640142572862 OPN NC SIS Medical AG LOX 2022-12-12 07640142572879 OPN NC SIS Medical AG LOX 2022-12-12 07640142572886 OPN NC SIS Medical AG LOX 2022-12-12 07640142572893 OPN NC SIS Medical AG LOX 2022-12-12 07640142572909 OPN NC SIS Medical AG LOX 2022-12-12 08033477048772 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048802 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048833 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048864 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048888 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048925 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048956 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048987 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049014 REEF HP MEDTRONIC, INC. LIT 2016-06-19
orbusneich.com