Ultra ICE™ Plus - PI

GUDID 08714729982500

Peripheral Imaging Catheter

BOSTON SCIENTIFIC 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

• Primary Device ID: 08714729982500
• NIH Device Record Key: 5311b0f2-fd52-440c-880b-13e43d38db7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra ICE™ Plus - PI
• Version Model Number: H7493932800990
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter
• Catheter Gauge: 8.5 French
• Length: 110 Centimeter
• Outer Diameter: 2.82 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729982500 [Primary]

FDA Product Code

• DXK: Echocardiograph

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: 2021-02-10
• Device Publish Date: 2021-02-02

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