EMBA Hourglass Peripheral Embolization Device

GUDID 00860002787107

EMBOLIC ACCELERATION, LLC

Non-neurovascular embolization plug, metallic

• Primary Device ID: 00860002787107
• NIH Device Record Key: 0a17a2e3-ed5b-4e49-b434-f2a6ca921225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBA Hourglass Peripheral Embolization Device
• Version Model Number: PEP-001-US
• Company DUNS: 114590580
• Company Name: EMBOLIC ACCELERATION, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002787107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171845

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2020-06-08
• Device Publish Date: 2020-05-29

Devices Manufactured by EMBOLIC ACCELERATION, LLC

• 00860002787107 - EMBA Hourglass Peripheral Embolization Device: 2020-06-08
• 00860002787107 - EMBA Hourglass Peripheral Embolization Device: 2020-06-08
• 00860002787114 - Hourglass Peripheral Embolization Device: 2020-06-08