ULTIPAQ CERECYTE CFS10030830

GUDID 00878528000235

ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 3mm x 8cm 190cm Contents: 1 Detachable Coil System

Medos International Sàrl

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 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 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: 00878528000235
• NIH Device Record Key: 90adb07e-045f-479f-8f56-fe2d89222956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTIPAQ CERECYTE
• Version Model Number: CFS100308-30
• Catalog Number: CFS10030830
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082739

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: 2015-09-20

On-Brand Devices [ULTIPAQ CERECYTE]

• 00878528000273: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 4mm x 8cm 190cm Contents: 1 Detachable Coil System
• 00878528000266: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 4mm x 6cm 190cm Contents: 1 Detachable Coil System
• 00878528000259: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 4mm x 4cm 190cm Contents: 1 Detachable Coil System
• 00878528000242: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 4mm x 2cm 190cm Contents: 1 Detachable Coil System
• 00878528000235: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 3mm x 8cm 190cm Contents: 1 Detachable Coil System
• 00878528000228: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 3mm x 6cm 190cm Contents: 1 Detachable Coil System
• 00878528000211: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 3mm x 4cm 190cm Contents: 1 Detachable Coil System
• 00878528000204: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 3mm x 2cm 190cm Contents: 1 Detachable Coil System
• 00878528000198: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2.5mm x 8cm 190cm Contents: 1 Detachable Coil System
• 00878528000181: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2.5mm x 6cm 190cm Contents: 1 Detachable Coil System
• 00878528000174: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2.5mm x 4cm 190cm Contents: 1 Detachable Coil System
• 00878528000167: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2.5mm x 2cm 190cm Contents: 1 Detachable Coil System
• 00878528000150: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 8cm 190cm Contents: 1 Detachable Coil System
• 00878528000143: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 6cm 190cm Contents: 1 Detachable Coil System
• 00878528000136: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 4cm 190cm Contents: 1 Detachable Coil System
• 00878528000129: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 3cm 190cm Contents: 1 Detachable Coil System
• 00878528000112: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 2cm 190cm Contents: 1 Detachable Coil System
• 00878528000105: ULTIPAQ microcoil ULTIPAQ 10 CERECYTE Coil 2mm x 1cm 190cm Contents: 1 Detachable Coil System