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 00199874783659 LIA Console LEADOPTIK INC. NQQ 2026-06-01 00810024671953 SSPC NXT Delivery Catheter CENTERPOINT SYSTEMS LLC DQY 2026-06-01 08718481740330 Guidion Short IMDS Operations B.V. DQY 2026-06-01 08718481740347 FlowGuide IMDS Operations B.V. DQY 2026-06-01 07613327623338 AXS Lift Stryker Corporation DQY 2025-03-04 07613327623376 AXS Lift Stryker Corporation DQY 2025-03-04 00763000270353 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-08 00763000270377 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-08 00763000270537 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-08 00763000270551 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-08 00763000270216 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270230 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270254 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270292 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270315 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270339 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270391 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270414 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270438 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270476 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270490 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270513 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270582 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270605 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 00763000270667 Solitaire™ X-PACK Micro Therapeutics, Inc. DQY 2019-11-07 07613327417203 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327417227 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 00847536041707 PhenomTM 17 Catheter Micro Therapeutics, Inc. DQY 2019-04-22 00847536041752 PhenomTM 17 Catheter Micro Therapeutics, Inc. DQY 2019-04-22 00847536041769 PhenomTM 17 Catheter Micro Therapeutics, Inc. DQY 2019-04-22