Home GUDID 00383790004183 Cronus™ HP - OTW PTA BALLOON CATHETER
Primary DI 00383790004183
Brand Cronus™ HP - OTW PTA BALLOON CATHETER
Company NIPRO MEDICAL CORPORATION
Model NCH+76045
Device description OTW High Pressure Peripheral Balloon Catheter
Published 2016-09-16
Public version status Update
Distribution status Not 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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00383790004183 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00383790004183 00383790004183 383790004183 0383790004183
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 797372554 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00383790011839 PRESSONE TRG001-000-000-001 2026-05-01 00383790012478 relasyringe SYPR-03GA-WP SYPR-03GA-WP6; SYPR-03GA-WP60 2026-05-01 00383790012515 relasyringe SYPR-03GA-WP-S-US SYPR-03GA-WP6-S-US; SYPR-03GA-WP60-S-US 2026-05-01 00383790008037 Nipro SafeTouch Needle SAH+1825-1M 2026-04-30 00383790008105 Nipro SafeTouch Needle SAH+2138-1M 2026-04-30 00383790008136 Nipro SafeTouch Needle SAH+2238-1M 2026-04-30 00383790012379 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-SRA 2025-12-19 00383790012386 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-MRA 2025-12-19 00383790012393 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-LRA 2025-12-19 00383790012409 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-XLRA 2025-12-19 00383790012416 Blood pressure cuff hose for SURDIAL DX Hemodialysis System HXA-CUFFH-GR35R 2025-12-19 40383790012377 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-SRA 2025-12-19 40383790012384 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-MRA 2025-12-19 40383790012391 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-LRA 2025-12-19 40383790012407 Blood pressure cuff for SURDIAL DX Hemodialysis System HXA-GCUFF-XLRA 2025-12-19 40383790012414 Blood pressure cuff hose for SURDIAL DX Hemodialysis System HXA-CUFFH-GR35R 2025-12-19 00383790004503 NIPRO TP-SURE TPSURE+1 2015-09-16 00383790011877 SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET BL+A226Y/V813-NIJ 2025-06-01 00383790011884 NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET BL+A217Y/V806-NIJ 2025-06-01 00383790011891 NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET BL+A209Y/V803-NIJ 2025-06-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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 08033477049045 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049069 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049076 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049106 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049137 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049168 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049199 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049212 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049229 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049250 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049281 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049311 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049373 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049434 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049397 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477049090 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048727 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048734 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048765 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048796 REEF HP MEDTRONIC, INC. LIT 2016-06-19 08033477048819 REEF HP MEDTRONIC, INC. LIT 2016-06-19
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