Home GUDID 10851498007227 CardioCurve Steerable Sheath
Primary DI 10851498007227
Brand CardioCurve Steerable Sheath
Company CIRCA Scientific, Inc.
Model CC-1061S
Published 2024-08-01
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 DYB Introducer, Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYB Introducer, Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851498007227 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10851498007227 10851498007227
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
Regulatory Flags# DUNS number 963223222 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10860237000207 S-CATH™ Esophageal Temperature Probe CS-27ST (Straight) 2019-03-25 10860237000214 S-CATH™ Esophageal Temperature Probe CS-2001 (65cm Length) 2016-09-23 10860237000238 S-CATH™ Esophageal Temperature Probe CS-2007 (65cm Length) 2016-09-23 10860237000245 S-CATH™ Esophageal Temperature Probe CS-2001 (50cm Length) 2016-09-23 30860237000218 S-CATH™ Esophageal Temperature Probe CS-2001 (65cm Length) 2016-09-23 30860237000232 S-CATH™ Esophageal Temperature Probe CS-2007 (65cm Length) 2016-09-23 30860237000249 S-CATH™ Esophageal Temperature Probe CS-2001 (50cm Length) 2016-09-23 10851498007395 PeriCross Epicardial Access Kit PC-1013 2025-07-23 10851498007432 CrossWise RF Transseptal System CW-1085C 2025-05-28 10851498007449 CrossWise RF Transseptal System CW-1085V 2025-05-28 10851498007456 CrossWise RF Transseptal System CW-1013F 2025-05-28 00851498007404 CIRCA Temperature Monitoring System CS-1000 (SW Ver 3.2) 2025-02-14 10851498007333 CrossWise RF Transseptal System CW-1085S 2024-12-02 10851498007340 CrossWise RF Transseptal System CW-1085A 2024-12-02 10851498007357 CrossWise RF Transseptal System CW-1012W 2024-12-02 10851498007364 CrossWise RF Transseptal System CW-1012C 2024-12-02 10851498007371 CrossWise Multi-Use RF Adapter Cable CW-1001 2024-12-02 00851498007381 CIRCA Temperature Monitoring System CS-1000 (SW Ver 3.1) 2024-10-31 10851498007197 CardioCurve Steerable Sheath CC-1040S 2024-08-01 10851498007203 CardioCurve Steerable Sheath CC-1040M 2024-08-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850084947001 Genie MAX CULTIV8 1, LLC DYB 2026-05-29 G440VIZ1750 Multiflex Vizaramed, Inc. DYB 2026-04-09 08498840011300 VYGON Vygon Corporation DYB 2019-04-08 08498840011317 VYGON Vygon Corporation DYB 2019-04-08 08498840011751 VYGON Vygon Corporation DYB 2019-04-08 08498840011768 VYGON Vygon Corporation DYB 2019-04-08 08498840011775 VYGON Vygon Corporation DYB 2019-04-08 08498840011782 VYGON Vygon Corporation DYB 2019-04-08 08498840011799 VYGON Vygon Corporation DYB 2019-04-08 08498840011805 VYGON Vygon Corporation DYB 2019-04-08 08498840011812 VYGON Vygon Corporation DYB 2019-04-08 08498840012215 VYGON Vygon Corporation DYB 2019-04-08 H965481030 ENVI NAVILYST MEDICAL, INC. DYB 2019-01-03 07613327459210 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459227 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 07613327459234 AXS VECTA 71 Stryker Corporation DYB 2018-10-26 00813502010664 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-30 00813502010237 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010244 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 00813502010558 Introducer Kit for Impella® Oscor Inc. DYB 2017-11-18 H965481080 Navylist NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355010 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355020 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355030 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355060 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355080 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355090 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355110 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355120 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355130 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07