Medusa Multi-Coil 002155

GUDID 10857798005000

ENDOSHAPE, INC.

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil

• Primary Device ID: 10857798005000
• NIH Device Record Key: cb75b147-8faa-4404-8312-8a331400eca1
• Commercial Distribution Discontinuation: 2017-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Medusa Multi-Coil
• Version Model Number: MMC-120
• Catalog Number: 002155
• Company DUNS: 788545692
• Company Name: ENDOSHAPE, INC.
• 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

Customer Support Contacts

• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com
• Phone: 844-870-5070
• Email: customerservice@endoshape.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10857798005000 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-09-23

On-Brand Devices [Medusa Multi-Coil]

• 10857798005024: MMC074-45
• 10857798005017: MMC-122
• 10857798005000: MMC-120