Marblehead Medical 100240

GUDID 00860003254608

BOSS Balloon Guide Catheter

MARBLEHEAD MEDICAL LLC

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00860003254608
• NIH Device Record Key: 474668b0-d1d2-4a74-91c6-3413d9ea03a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Marblehead Medical
• Version Model Number: 100240
• Catalog Number: 100240
• 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: true
• 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	00860003254608 [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: true

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