MICRUSPHERE CERECYTE CSP10090030

GUDID 00878528001096

MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 9mm x 18.4cm 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: 00878528001096
• NIH Device Record Key: 9327754e-822e-4610-b454-6ad0193d7704
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICRUSPHERE CERECYTE
• Version Model Number: CSP100900-30
• Catalog Number: CSP10090030
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528001096 [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 [MICRUSPHERE CERECYTE]

• 00878528001362: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 18mm x 30cm 190cm Contents: 1 Detachable Coil
• 00878528001355: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 17mm x 30cm 190cm Contents: 1 Detachable Coil
• 00878528001348: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 16mm x 27.9cm 190cm Contents: 1 Detachable Co
• 00878528001331: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 15mm x 26cm 190cm Contents: 1 Detachable Coil
• 00878528001324: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 14mm x 24.3cm 190cm Contents: 1 Detachable Co
• 00878528001317: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 13mm x 22.6cm 190cm Contents: 1 Detachable Co
• 00878528001300: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 12mm x 20.7cm 190cm Contents: 1 Detachable Co
• 00878528001294: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 11mm x 18.9cm 190cm Contents: 1 Detachable Co
• 00878528001287: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 10mm x 17.1cm 190cm Contents: 1 Detachable Co
• 00878528001270: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 9mm x 15.3cm 190cm Contents: 1 Detachable Coi
• 00878528001263: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 8mm x 13.6cm 190cm Contents: 1 Detachable Coi
• 00878528001256: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 7mm x 14.3cm 190cm Contents: 1 Detachable Coi
• 00878528001249: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 6mm x 12.2cm 190cm Contents: 1 Detachable Coi
• 00878528001232: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 5mm x 10cm 190cm Contents: 1 Detachable Coil
• 00878528001225: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 4mm x 7.9cm 190cm Contents: 1 Detachable Coil
• 00878528001218: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 3mm x 5.8cm 190cm Contents: 1 Detachable Coil
• 00878528001201: MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 2mm x 2.7cm 190cm Contents: 1 Detachable Coil
• 00878528001102: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 10mm x 20.3cm 190cm Contents: 1 Detachable Co
• 00878528001096: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 9mm x 18.4cm 190cm Contents: 1 Detachable Coi
• 00878528001089: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 8mm x 16.1cm 190cm Contents: 1 Detachable Coi
• 00878528001072: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 7mm x 13.9cm 190cm Contents: 1 Detachable Coi
• 00878528001065: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 6mm x 11.9cm 190cm Contents: 1 Detachable Coi
• 00878528001058: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 5mm x 9.7cm 190cm Contents: 1 Detachable Coil
• 00878528001041: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 4mm x 7.5cm 190cm Contents: 1 Detachable Coil
• 00878528001034: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 3.5mm x 6.6cm 190cm Contents: 1 Detachable Co
• 00878528001027: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 3mm x 5.4cm 190cm Contents: 1 Detachable Coil
• 00878528001010: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 2.5mm x 3.3cm 190cm Contents: 1 Detachable Co
• 00878528001003: MICRUSPHERE microcoil MICRUSPHERE 10 CERECYTE Coil 2mm x 2.5cm 190cm Contents: 1 Detachable Coil