Reconnaissance PV .018 OTW Digital IVUS Catheter

GUDID 00845225003067

Philips Image Guided Therapy Corporation

Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 00845225003067
• NIH Device Record Key: 233fbff9-9004-44b2-a2b7-8e1ea89e13a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reconnaissance PV .018 OTW Digital IVUS Catheter
• Version Model Number: 018OTW
• Company DUNS: 018860556
• Company Name: Philips Image Guided Therapy Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225003067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200410

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-06
• Device Publish Date: 2021-07-29

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