ENPOWER

Basic Information

• Brand Name: ENPOWER
• Primary DI: 00878528000044
• Version / Model: ECB000182-00
• Catalog Number: ECB00018200
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 6
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 90a25854-21eb-4780-bf94-6a6aed398597

Device Description

ENPOWER Control Cable Contents: 1 EnPOWER Control Cable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION	Neurology	882.5950	2
KRD	Device, Vascular, for Promoting Embolization	Cardiovascular	870.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60637	Vascular implant detacher, electronic, single-use	A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878528000044	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142429	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius