Home GUDID 00851354004189 Ocelot III
Primary DI 00851354004189
Brand Ocelot III
Company AVINGER, INC.
Model O200
Catalog number O200
Device description The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Published 2019-03-21
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 DQY Catheter, Percutaneous NQQ System, Imaging, Optical Coherence Tomography (Oct)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851354004189 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 00851354004189 00851354004189 851354004189 0851354004189
GMDN Terms# Term, Definition table Term Definition Mechanical atherectomy system, coronary/peripheral An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 003152968 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10801902189452 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 10801902218145 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 10801902219692 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 10801902219708 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 10801902219715 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 10801902220445 ARROW TELEFLEX INCORPORATED DQY 2026-08-01 08718122006153 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122006160 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122008188 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122008195 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122013922 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122014103 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 08718122028902 Primum Guiding Catheter PendraCare International B.V. DQY 2026-07-30 10841156108915 TRAPLINER TELEFLEX INCORPORATED DQY 2026-07-30 10801902196719 ARROW TELEFLEX INCORPORATED DQY 2026-07-29 10841156108892 TRAPLINER TELEFLEX INCORPORATED DQY 2026-07-29 00884450419922 SureCross Merit Medical Systems, Inc. DQY 2026-07-24 10841156108908 TRAPLINER TELEFLEX INCORPORATED DQY 2026-07-23 06934955914713 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914720 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914737 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914744 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914751 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914768 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914775 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914782 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914799 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914805 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914812 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20 06934955914829 Teleport Glide Microcatheter OrbusNeich Medical (ShenZhen) Co., Ltd. DQY 2026-07-20