MICRUSPHERE CERECYTE CSP18090030

GUDID 00878528001270

MICRUSPHERE microcoil MICRUSPHERE 18 CERECYTE Coil 9mm x 15.3cm 190cm Contents: 1 Detachable Coil System

Medos International Sàrl

Neurovascular embolization coil

• Primary Device ID: 00878528001270
• NIH Device Record Key: ccf5eaa1-c6de-4c01-b571-962181420834
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICRUSPHERE CERECYTE
• Version Model Number: CSP180900-30
• Catalog Number: CSP18090030
• 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
• Handling 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 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 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
• 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 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
• 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 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
• 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 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
• 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 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
• 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 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
• 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 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
• 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 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528001270 [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