FDA.reportPublic FDA data

MReye

Primary DI
00827002203259
Brand
MReye
Company
COOK INCORPORATED
Model
G20325
Catalog number
IMWCE-38-6-12
Device description
MReye Embolization Coil
Published
2017-02-08
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150931000MReye Embolization CoilsCook Incorporated2015-12-18KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002203259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002203259008270022032598270022032590827002203259

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
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488710Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28