CERECYTE PRESIDIO PC410041230

GUDID 00878528003007

PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 4mm x 11.5cm 190cm Contents: 1 Detachable Coil System

Medos International Sàrl

Neurovascular embolization coil

• Primary Device ID: 00878528003007
• NIH Device Record Key: 754b0165-2703-4298-b951-7c857c76fb15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERECYTE PRESIDIO
• Version Model Number: PC4100412-30
• Catalog Number: PC410041230
• 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 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528003007 [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 [CERECYTE PRESIDIO]

• 00878528003328: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 20mm x 50cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003311: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 19mm x 50cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003304: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 18mm x 46cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003298: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 17mm x 50cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003281: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 16mm x 47cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003274: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 15mm x 50cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003267: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 14mm x 47cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003250: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 13mm x 43cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003243: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 12mm x 40cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003236: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 11mm x 37cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003229: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 10mm x 34cm 190cm Contents: 1 Detachable Coil Syste
• 00878528003212: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 9mm x 33cm 190cm Contents: 1 Detachable Coil System
• 00878528003205: PRESIDIO microcoil PRESIDIO 18 CERECYTE Coil 8mm x 30cm 190cm Contents: 1 Detachable Coil System
• 00878528003045: PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 8mm x 29cm 190cm Contents: 1 Detachable Coil System
• 00878528003038: PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 7mm x 30cm 190cm Contents: 1 Detachable Coil System
• 00878528003021: PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 6mm x 26cm 190cm Contents: 1 Detachable Coil System
• 00878528003014: PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 5mm x 17cm 190cm Contents: 1 Detachable Coil System
• 00878528003007: PRESIDIO microcoil PRESIDIO 10 CERECYTE Coil 4mm x 11.5cm 190cm Contents: 1 Detachable Coil Syst