IOPS™ SSH-1

GUDID 10843152102010

IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system

CENTERLINE BIOMEDICAL, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10843152102010
• NIH Device Record Key: 3db94fa6-6db9-45f5-9d6e-1ffa6122cf72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOPS™
• Version Model Number: SSH-1
• Catalog Number: SSH-1
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00843152102013 [Primary]
GS1	10843152102010 [Package]; Contains: 00843152102013; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190106

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: 2020-10-29
• Device Publish Date: 2020-10-21

On-Brand Devices [IOPS™]

• 10843152102010: IOPS™ Guidewire 2 Handle for connection of guidewire sensor to system
• 10843152101037: IOPS™ Catheter Reverse Curve 1
• 10843152101020: IOPS™ Catheter Simple Curve 1
• 10843152103000: IOPS™ Tracking Pad 1