MReye IMWCE-35-1.5-5

GUDID 00827002199927

MReye Embolization Coil

COOK INCORPORATED

Non-neurovascular embolization coil

• Primary Device ID: 00827002199927
• NIH Device Record Key: d4186009-2442-4c94-a890-512ef03a48ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MReye
• Version Model Number: G19992
• Catalog Number: IMWCE-35-1.5-5
• 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	00827002199927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150931

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: 2018-07-06
• Device Publish Date: 2017-02-08

On-Brand Devices [MReye]

• 00827002128415: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002115880: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002115873: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002115842: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002115835: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002113244: MReye, Disposable Chiba Biopsy Needle Inconel
• 00827002529847: MReye Embolization Coil
• 00827002529830: MReye Embolization Coil
• 00827002529823: MReye Embolization Coil
• 00827002529816: MReye Embolization Coil
• 00827002529809: MReye Embolization Coil
• 00827002529793: MReye Embolization Coil
• 00827002479395: MReye Embolization Coil
• 00827002479388: MReye Embolization Coil
• 00827002479371: MReye Embolization Coil
• 00827002479364: MReye Embolization Coil
• 00827002479357: MReye Embolization Coil
• 00827002479340: MReye Embolization Coil
• 00827002479333: MReye Embolization Coil
• 00827002479326: MReye Embolization Coil
• 00827002479319: MReye Embolization Coil
• 00827002479302: MReye Embolization Coil
• 00827002479296: MReye Embolization Coil
• 00827002479289: MReye Embolization Coil
• 00827002479272: MReye Embolization Coil
• 00827002479265: MReye Embolization Coil
• 00827002479258: MReye Embolization Coil
• 00827002479241: MReye Embolization Coil
• 00827002479234: MReye Embolization Coil
• 00827002479227: MReye Embolization Coil
• 00827002479210: MReye Embolization Coil
• 00827002479203: MReye Embolization Coil
• 00827002479197: MReye Embolization Coil
• 00827002479180: MReye Embolization Coil
• 00827002479173: MReye Embolization Coil
• 00827002479166: MReye Embolization Coil
• 00827002479159: MReye Embolization Coil
• 00827002479142: MReye Embolization Coil
• 00827002479135: MReye Embolization Coil
• 00827002479128: MReye Embolization Coil
• 00827002479111: MReye Embolization Coil
• 00827002479104: MReye Embolization Coil
• 00827002479098: MReye Embolization Coil
• 00827002479081: MReye Embolization Coil
• 00827002479074: MReye Embolization Coil
• 00827002479067: MReye Embolization Coil
• 00827002479050: MReye Embolization Coil
• 00827002479043: MReye Embolization Coil
• 00827002479036: MReye Embolization Coil
• 00827002479029: MReye Embolization Coil