COBRA-OS™ F01K1

GUDID 10628678061009

The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

Front Line Medical Technologies Inc.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 10628678061009
• NIH Device Record Key: 6e328f72-05e9-4cd2-a9a7-52dd3e0b697e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COBRA-OS™
• Version Model Number: F01K1
• Catalog Number: F01K1
• Company DUNS: 242512799
• Company Name: Front Line Medical Technologies Inc.
• 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: true
• 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	10628678061009 [Primary]
GS1	16286780610009 [Previous]
GS1	20628678061006 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201652

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [COBRA-OS™]

• 16286780610009: The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin
• 16286780610016: The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin
• 10628678061016: The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin
• 10628678061009: The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin