Home GUDID 10851498007395 PeriCross Epicardial Access Kit
Primary DI 10851498007395
Brand PeriCross Epicardial Access Kit
Company CIRCA Scientific, Inc.
Model PC-1013
Published 2025-07-23
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 10851498007395 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10851498007395 10851498007395
GMDN Terms# Term, Definition table Term Definition Epicardial catheter introduction set A collection of sterile, invasive, non-steerable devices intended to provide percutaneous sub-xiphoid access to enable introduction of a diagnostic catheter (not included) to the epicardial surface of the heart. It primarily includes: 1) a percutaneous introducer sleeve/tunneller with obturator, intended for initial introduction; 2) a retracting mechanism, intended to grab and separate the pericardium from the epicardial surface; 3) a needle, intended to puncture the pericardium; and 4) a haemostatic valve. 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 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 10851498007210 CardioCurve Steerable Sheath CC-1040L 2024-08-01
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