Home GUDID 00801741129698 Halo One™ Thin-Walled Guiding Sheath
Primary DI 00801741129698
Brand Halo One™ Thin-Walled Guiding Sheath
Company CLEARSTREAM TECHNOLOGIES LIMITED
Model HAL510F
Catalog number HAL510F
Device description Halo One Thin-Walled Guiding Sheath 5F x 10cm
Published 2016-06-10
Public version status Update
Distribution status Not 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 10801741129695 Package GS1 5 Not in Commercial Distribution 00801741129698 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 10801741129695 10801741129695 00801741129698 00801741129698 801741129698 0801741129698
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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. 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
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 false 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 00801741219139 Halo One Thin-Walled Guiding Sheath HLO61018FH HLO61018FH 2021-11-15 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884450838211 Prelude Roadster™ Merit Medical Systems, Inc. DYB 2026-08-18 00199874352930 Transseptal Puncture Device PROTARYX MEDICAL INC. DYB 2026-07-15 00198715836998 EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING FREUDENBERG MEDICAL, LLC DYB 2026-01-29 00685447005285 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005292 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005308 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005315 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005322 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005339 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005346 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005353 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005360 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005377 TorFlex Transseptal Guiding Sheath Baylis Médicale Cie Inc DYB 2021-11-01 00685447005384 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005391 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005407 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005414 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005421 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005438 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005445 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005452 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005469 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 00685447005476 TorFlex Transseptal Guiding Sheath BOSTON SCIENTIFIC CORPORATION DYB 2021-11-01 10801902190519 ARROW TELEFLEX INCORPORATED DYB 2021-09-02 00685447005605 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005612 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005629 SupraCross Steerable Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00685447005643 SureFlex Steerable Guiding Sheath Baylis Médicale Cie Inc DYB 2021-04-19 00389701012353 R2P Destination Slender TERUMO MEDICAL CORPORATION DYB 2020-04-10 00389701012360 R2P Destination Slender TERUMO MEDICAL CORPORATION DYB 2020-04-10