Home GUDID 00850021246082 CrossWise
Primary DI 00850021246082
Brand CrossWise
Company KALILA MEDICAL, INC.
Model CW-STS8F25
Device description Steerable Transseptal Sheath
Published 2022-02-01
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 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 00850021246082 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 00850021246082 00850021246082 850021246082 0850021246082
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 015986592 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 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 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 H965355160 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355170 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355180 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965355190 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07 H965481000 ENVI NAVILYST MEDICAL, INC. DYB 2017-08-07
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