FDA.reportPublic FDA data

MReye Flipper

Primary DI
00827002483569
Brand
MReye Flipper
Company
William Cook Europe ApS
Model
G48356
Catalog number
IFMWCE-35-6-6.5
Device description
MReye Flipper, Detachable Embolization Coil
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00827002483569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002483569008270024835698270024835690827002483569

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization coilA sterile, non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
305302119
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
true
Expiration date on label
true
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
10827002601595Zenith AlphaG60159ZTA2-D-28-160-W2024-12-18
10827002601656Zenith AlphaG60165ZTA2-D-30-160-W2024-12-18
10827002601717Zenith AlphaG60171ZTA2-D-32-160-W2024-12-18
10827002601748Zenith AlphaG60174ZTA2-D-32-229-W2024-12-18
10827002601779Zenith AlphaG60177ZTA2-D-34-142-W2024-12-18
10827002601809Zenith AlphaG60180ZTA2-D-34-190-W2024-12-18
10827002601830Zenith AlphaG60183ZTA2-D-36-142-W2024-12-18
10827002601861Zenith AlphaG60186ZTA2-D-36-190-W2024-12-18
10827002601892Zenith AlphaG60189ZTA2-D-38-147-W2024-12-18
10827002601922Zenith AlphaG60192ZTA2-D-38-197-W2024-12-18
10827002601953Zenith AlphaG60195ZTA2-D-40-147-W2024-12-18
10827002601984Zenith AlphaG60198ZTA2-D-40-197-W2024-12-18
10827002602011Zenith AlphaG60201ZTA2-D-42-152-W2024-12-18
10827002602042Zenith AlphaG60204ZTA2-D-42-204-W2024-12-18
10827002602073Zenith AlphaG60207ZTA2-D-44-157-W2024-12-18
10827002602103Zenith AlphaG60210ZTA2-D-44-211-W2024-12-18
10827002602127Zenith AlphaG60212ZTA2-D-46-211-W2024-12-18
10827002602158Zenith AlphaG60215ZTA2-D-46-157-W2024-12-18
10827002599816Zenith AlphaG59981ZTA2-P-30-132-W2024-12-04
10827002599847Zenith AlphaG59984ZTA2-P-30-155-W2024-12-04

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Primary DI, Brand, Company table
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