R-100 Pullback Device 804547001

GUDID 00184360000327

VOLCANO CORPORATION

Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable Intravascular ultrasound imaging catheter extractor, reusable

• Primary Device ID: 00184360000327
• NIH Device Record Key: 31b086f6-4147-446f-8c29-8627d17d0ff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-100 Pullback Device
• Version Model Number: R100
• Catalog Number: 804547001
• Company DUNS: 135179237
• Company Name: VOLCANO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00184360000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962293

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

Devices Manufactured by VOLCANO CORPORATION

• 20845225012681 - SpinVision STERILE EQUIPEMENT COVER: 2021-10-26
• 20845225012698 - DIGITAL IVUS STERILE EQUIPEMENT COVER: 2021-10-26
• 10845225012707 - R-100 STERILE EQUIPEMENT COVER: 2021-10-26
• 00845225012915 - IntraSight Mobile: 2021-02-03
• 00845225012847 - FM-PIM: 2021-01-29
• 00845225012656 - CORE FM CART: 2020-06-02
• 00845225010874 - ComboMap Pressure and Flow System: 2020-01-01
• 00845225002565 - Pioneer Plus Catheter: 2019-03-21