Home GUDID 00801741133084 Savvy Long PTA Dilatation Catheter
Primary DI 00801741133084
Brand Savvy Long PTA Dilatation Catheter
Company CLEARSTREAM TECHNOLOGIES LIMITED
Model 436-3518S
Catalog number 436-3518S
Device description Savvy Long PTA Dilatation Catheter 3.5mm x 180mm balloon, 80cm shaft
Published 2016-09-16
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 LIT Catheter, angioplasty, peripheral, transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00801741133084 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 00801741133084 00801741133084 801741133084 0801741133084
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. 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 Device Size Text, specify 0
Regulatory Flags# DUNS number 989214291 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 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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