Home GUDID 10801741184847 Halo One™ Thin-Walled Guiding Sheath
Primary DI 10801741184847
Brand Halo One™ Thin-Walled Guiding Sheath
Company CLEARSTREAM TECHNOLOGIES LIMITED
Model HLO51035H
Catalog number HLO51035H
Device description Halo One 5F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic coating
Published 2020-04-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 10801741184847 Package GS1 5 In Commercial Distribution 00801741184840 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 10801741184847 10801741184847 00801741184840 00801741184840 801741184840 0801741184840
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.
Regulatory Flags# DUNS number 989214291 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00801741184802 Halo One™ Thin-Walled Guiding Sheath HLO41018FH HLO41018FH 2020-04-27 00801741184819 Halo One™ Thin-Walled Guiding Sheath HLO41035FH HLO41035FH 2020-04-27 00801741184833 Halo One™ Thin-Walled Guiding Sheath HLO51018FH HLO51018FH 2020-04-27 00801741184840 Halo One™ Thin-Walled Guiding Sheath HLO51035FH HLO51035FH 2020-04-27 00801741184864 Halo One™ Thin-Walled Guiding Sheath HLO61035FH HLO61035FH 2020-04-27 00801741223778 Halo One Thin-Walled Guiding Sheath HLO41018FHK HLO41018FHK 2021-12-14 00801741223785 Halo One Thin-Walled Guiding Sheath HLO41035FHK HLO41035FHK 2021-12-14 00801741223815 Halo One Thin-Walled Guiding Sheath HLO51018FHK HLO51018FHK 2021-12-14 00801741223822 Halo One Thin-Walled Guiding Sheath HLO51035FHK HLO51035FHK 2021-12-14 00801741223853 Halo One Thin-Walled Guiding Sheath HLO61035FHK HLO61035FHK 2021-12-14 00801741223907 Halo One Thin-Walled Guiding Sheath HLO61018FHK HLO61018FHK 2021-12-14 00801741184826 Halo One™ Thin-Walled Guiding Sheath HLO42535H HLO42535H 2020-04-27 00801741184857 Halo One™ Thin-Walled Guiding Sheath HLO52535H HLO52535H 2020-04-27 00801741184871 Halo One™ Thin-Walled Guiding Sheath HLO62535H HLO62535H 2020-04-27 00801741223792 Halo One Thin-Walled Guiding Sheath HLO42518HK HLO42518HK 2021-12-14 00801741223808 Halo One Thin-Walled Guiding Sheath HLO42535HK HLO42535HK 2021-12-14 00801741223839 Halo One Thin-Walled Guiding Sheath HLO52518HK HLO52518HK 2021-12-14 00801741223846 Halo One Thin-Walled Guiding Sheath HLO52535HK HLO52535HK 2021-12-14 00801741223860 Halo One Thin-Walled Guiding Sheath HLO62535HK HLO62535HK 2021-12-14 00801741223914 Halo One Thin-Walled Guiding Sheath HLO62518HK HLO62518HK 2021-12-14
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