EMBOGUARD BG8795U

GUDID 10886704082743

EMBOGUARD Balloon Guide Catheter

NEURAVI LIMITED

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 10886704082743
• NIH Device Record Key: 66f83f77-8ce2-4021-897e-849b7a89d516
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBOGUARD
• Version Model Number: BG8795U
• Catalog Number: BG8795U
• Company DUNS: 985010416
• Company Name: NEURAVI LIMITED
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704082743 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212340

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: 2021-12-30
• Device Publish Date: 2021-12-22

On-Brand Devices [EMBOGUARD]

• 10886704082743: EMBOGUARD Balloon Guide Catheter
• 10886704082736: EMBOGUARD Balloon Guide Catheter