Hilal MWCE-18-3.0-3-HILAL-01

GUDID 00827002475106

Hilal Embolization Microcoil

COOK INCORPORATED

Non-neurovascular embolization coil

• Primary Device ID: 00827002475106
• NIH Device Record Key: 29bd9609-8a65-44e7-bc19-b45f5a717083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hilal
• Version Model Number: G47510
• Catalog Number: MWCE-18-3.0-3-HILAL-01
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: true
• 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: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002475106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160219

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: 2018-10-05
• Device Publish Date: 2018-09-04

On-Brand Devices [Hilal]

• 00827002081253: Hilal Embolization Microcoil
• 00827002071612: Hilal Embolization Microcoil
• 00827002071605: Hilal Embolization Microcoil
• 00827002071599: Hilal Embolization Microcoil
• 00827002071582: Hilal Embolization Microcoil
• 00827002071575: Hilal Embolization Microcoil
• 00827002071568: Hilal Embolization Microcoil
• 00827002071551: Hilal Embolization Microcoil
• 00827002071544: Hilal Embolization Microcoil
• 00827002071537: Hilal Embolization Microcoil
• 00827002050174: Hilal Embolization Microcoil
• 00827002046221: Hilal Embolization Microcoil
• 00827002046214: Hilal Embolization Microcoil
• 00827002046207: Hilal Embolization Microcoil
• 00827002046191: Hilal Embolization Microcoil
• 00827002045255: Hilal Embolization Microcoil
• 00827002045248: Hilal Embolization Microcoil
• 00827002045231: Hilal Embolization Microcoil
• 00827002045224: Hilal Embolization Microcoil
• 00827002475168: Hilal Embolization Microcoil
• 00827002475151: Hilal Embolization Microcoil
• 00827002475144: Hilal Embolization Microcoil
• 00827002475137: Hilal Embolization Microcoil
• 00827002475120: Hilal Embolization Microcoil
• 00827002475113: Hilal Embolization Microcoil
• 00827002475106: Hilal Embolization Microcoil
• 00827002475090: Hilal Embolization Microcoil
• 00827002475083: Hilal Embolization Microcoil
• 00827002475076: Hilal Embolization Microcoil
• 00827002475069: Hilal Embolization Microcoil
• 00827002475052: Hilal Embolization Microcoil
• 00827002475045: Hilal Embolization Microcoil
• 00827002475038: Hilal Embolization Microcoil
• 00827002475021: Hilal Embolization Microcoil
• 00827002475014: Hilal Embolization Microcoil
• 00827002475007: Hilal Embolization Microcoil
• 00827002474994: Hilal Embolization Microcoil
• 00827002474987: Hilal Embolization Microcoil