Azur Detachment Controller

Primary DI
00810170012129
Brand
Azur Detachment Controller
Company
Microvention, Inc.
Model
45-4001
Catalog number
45-4001
Device description
Azur
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810170012126PackageGS15In Commercial Distribution
00810170012129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081017001212610810170012126
00810170012129008101700121298101700121290810170012129

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, electronic, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(714)247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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00842429113622ISAACINN6140TIP45INN6140TIP452025-04-30
00842429108444SofiaDA6115ST-GC-ODDA6115ST2024-10-18
00842429108451SofiaDA6125ST-GC-ODDA6125ST2024-10-18
00842429108468SofiaDA6131ST-GC-ODDA6131ST2024-10-18
00842429118092AccessISC5115ST-RAISC5115ST2024-10-18
00842429117705SOFIA 88DA8115ST-DAC-USDA8115ST2023-06-15
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
04987350999795Sofia 5F-125cm STRDA5125STDA5125ST2016-09-24
00816777025913Sofia 5F-125cm STRDA5125ST-EDA5125ST2018-08-07
00816777025920Sofia 5F-115cm STRDA5115ST-EDA5115ST2018-08-07
00812636020082Sofia 5F-115cm STRDA5115STDA5115ST2016-09-24
00812636020419Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020426Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24
00812636020433Sofia 6F-135cm STRDA6135STDA6135ST2016-09-24
00812636020440Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020457Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24

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