Target 615615

GUDID 07613252516439

3D Detachable Coil

Stryker Corporation

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

• Primary Device ID: 07613252516439
• NIH Device Record Key: f3f532f8-93da-410e-962f-69ee06d12d3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Target
• Version Model Number: M0036156150
• Catalog Number: 615615
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• 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: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com
• Phone: +1(855)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252516439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123377

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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: 2015-09-21

On-Brand Devices [Target]

• 07613327128413: XXL 360 Detachable Coil
• 07613327128406: XXL 360 Detachable Coil
• 07613327128383: XXL 360 Detachable Coil
• 07613327128376: XXL 360 Detachable Coil
• 07613327128369: XXL 360 Detachable Coil
• 07613327128352: XXL 360 Detachable Coil
• 07613327128345: XXL 360 Detachable Coil
• 07613327128307: XXL 360 Detachable Coil
• 07613327004830: 3D Detachable Coil
• 07613327004823: 3D Detachable Coil
• 07613327004816: Helical Ultra Detachable Coil
• 07613252600442: Helical Nano Detachable Coil
• 07613252600435: Helical Nano Detachable Coil
• 07613252600428: Helical Nano Detachable Coil
• 07613252600411: Helical Nano Detachable Coil
• 07613252600404: Helical Nano Detachable Coil
• 07613252600398: Helical Nano Detachable Coil
• 07613252600381: Helical Nano Detachable Coil
• 07613252600374: Helical Nano Detachable Coil
• 07613252600367: Helical Nano Detachable Coil
• 07613252600350: Helical Nano Detachable Coil
• 07613252600343: 360 Nano Detachable Coil
• 07613252600336: 360 Nano Detachable Coil
• 07613252600329: 360 Nano Detachable Coil
• 07613252600312: 360 Nano Detachable Coil
• 07613252600305: 360 Nano Detachable Coil
• 07613252600299: 360 Nano Detachable Coil
• 07613252516453: 3D Detachable Coil
• 07613252516439: 3D Detachable Coil
• 07613252239475: 360 Soft Detachable Coil
• 07613252239444: 360 Standard Detachable Coil
• 07613252239420: 360 Standard Detachable Coil
• 07613252239413: 360 Standard Detachable Coil
• 07613252239345: 360 Ultra Detachable Coil
• 07613252192756: 360 Soft Detachable Coil
• 07613252192701: 360 Soft Detachable Coil
• 07613252192695: 360 Soft Detachable Coil
• 07613252192688: 360 Soft Detachable Coil
• 07613252192671: 360 Soft Detachable Coil
• 07613252192664: 360 Soft Detachable Coil
• 07613252192640: 360 Soft Detachable Coil
• 07613252192633: 360 Standard Detachable Coil
• 07613252192602: 360 Standard Detachable Coil
• 07613252192558: 360 Standard Detachable Coil
• 07613252192541: 360 Standard Detachable Coil
• 07613252192534: 360 Standard Detachable Coil
• 07613252192527: 360 Standard Detachable Coil
• 07613252192510: 360 Standard Detachable Coil
• 07613252192503: 360 Standard Detachable Coil
• 07613252192497: 360 Standard Detachable Coil