IOPS Viewpoint C01252

GUDID 10843152101112

Double Curve Catheter, 125 cm

CENTERLINE BIOMEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 10843152101112
• NIH Device Record Key: 2eb512ba-43ed-480f-90b1-8116c9c9f2ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOPS Viewpoint
• Version Model Number: C01252
• Catalog Number: C01252
• Company DUNS: 080088507
• Company Name: CENTERLINE BIOMEDICAL, INC.
• 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: 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 Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch
• Catheter Working Length: 125 Centimeter
• Catheter Length: 135 Centimeter
• Catheter Gauge: 6 French
• Catheter Inner Diameter: 0.035 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843152101115 [Primary]
GS1	10843152101112 [Package]; Contains: 00843152101115; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241243

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

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: 2024-10-09
• Device Publish Date: 2024-10-01

On-Brand Devices [IOPS Viewpoint]

• 10843152101112: Double Curve Catheter, 125 cm
• 10843152101105: Double Curve Catheter, 75 cm
• 10843152101075: Simple Curve Catheter, 125 cm
• 00843152101061: Simple Curve Catheter, 75 cm