Marblehead Medical 100240-D

GUDID 00860003254615

BOSS Balloon Guide Catheter, DEMO UNIT, Not for Human Use

MARBLEHEAD MEDICAL LLC

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 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: 00860003254615
• NIH Device Record Key: 3b26ecbf-b2ed-4d92-aca6-5a5f2385d995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Marblehead Medical
• Version Model Number: 100240-D
• Catalog Number: 100240-D
• Company DUNS: 080473303
• Company Name: MARBLEHEAD MEDICAL LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003254615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200910

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-30
• Device Publish Date: 2020-10-22

On-Brand Devices [Marblehead Medical]

• 08600032546013: BOSS Balloon Guide Catheter
• 08600032546006: BOSS Balloon Guide Catheter, Demo Unit, Not for Human Use
• 00860003254615: BOSS Balloon Guide Catheter, DEMO UNIT, Not for Human Use
• 00860003254608: BOSS Balloon Guide Catheter