IOPS® H01035

GUDID 10843152102058

Guidewire Handle

CENTERLINE BIOMEDICAL, INC.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 10843152102058
• NIH Device Record Key: 3b353049-d1b8-4ad1-b479-ea49133fb80e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOPS®
• Version Model Number: H01035
• Catalog Number: H01035
• 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	00843152102051 [Primary]
GS1	10843152102058 [Package]; Contains: 00843152102051; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242133

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: 2024-11-19
• Device Publish Date: 2024-11-11

Devices Manufactured by CENTERLINE BIOMEDICAL, INC.

• 10843152102058 - IOPS®: 2024-11-19Guidewire Handle
• 10843152102058 - IOPS®: 2024-11-19 Guidewire Handle
• 00843152101061 - IOPS Viewpoint: 2024-10-09 Simple Curve Catheter, 75 cm
• 10843152101075 - IOPS Viewpoint: 2024-10-09 Simple Curve Catheter, 125 cm
• 10843152101105 - IOPS Viewpoint: 2024-10-09 Double Curve Catheter, 75 cm
• 10843152101112 - IOPS Viewpoint: 2024-10-09 Double Curve Catheter, 125 cm
• 10843152103000 - IOPS™: 2023-09-18 IOPS™ Tracking Pad 1
• 10843152101020 - IOPS™: 2021-12-22 IOPS™ Catheter Simple Curve 1
• 10843152101037 - IOPS™: 2021-12-22 IOPS™ Catheter Reverse Curve 1