ENPOWER ECB00018200

GUDID 00878528000044

EnPOWER Control Cable Contents: 1 EnPOWER Control Cable

Medos International Sàrl

Vascular implant detacher, single-use, sterile Vascular implant detacher, single-use, sterile Vascular implant detacher, single-use, sterile Vascular implant detacher, single-use, sterile Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use Vascular implant detacher, electronic, single-use

• Primary Device ID: 00878528000044
• NIH Device Record Key: 90a25854-21eb-4780-bf94-6a6aed398597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENPOWER
• Version Model Number: ECB000182-00
• Catalog Number: ECB00018200
• 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
• Storage 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
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• 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 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 110 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528000044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142429

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 [ENPOWER]

• 00878528000051: EnPOWER Detachment Control Box Contents: 1 EnPOWER Detachment Control Box
• 00878528000044: EnPOWER Control Cable Contents: 1 EnPOWER Control Cable
• 10886704080428: EnPOWER detachment control box Contents: 1 EnPOWER Detachment Control Box