FDA.reportPublic FDA data

ENPOWER

Primary DI
10886704080428
Brand
ENPOWER
Company
Cerenovus, Inc.
Model
DCB2000500
Catalog number
DCB2000500
Device description
EnPOWER Detachment Control Box Contents: 1 EnPOWER Detachment Control Box
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071246000MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STRMicrus Endovascular Corporation2007-06-01HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704080428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408042810886704080428

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, electronic, reusableA 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Waste from electrical and electronic equipment
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20
10886704077299DELTAXSFTDLX100201DLX1002012016-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
00816777020116V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
00840273202028V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
00842429106464V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
10886704080121GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080138GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080145GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080152GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080220GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080237GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080244GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080251GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080268GALAXY G3Cerenovus, Inc.HCG2017-11-03