FDA.reportPublic FDA data

GuardWire®

Primary DI
10721902644174
Brand
GuardWire®
Company
MEDTRONIC, INC.
Model
GEZ6300US
Device description
KIT GEZ6300US GUARD 6F EZA 3-6OTW
Published
2016-05-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFATemporary Coronary Saphenous Vein Bypass Graft for Embolic Protection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10721902644174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1072190264417410721902644174

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length300Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729470854FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729470861FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729479109EZ Bent TipBOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808800FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
08714729808817FilterWire EZ™BOSTON SCIENTIFIC CORPORATIONNFA2016-09-24
10721902644020GuardWire®MEDTRONIC, INC.NFA2016-09-01
10721902644037GuardWire®MEDTRONIC, INC.NFA2016-05-15
10721902644167GuardWire®MEDTRONIC, INC.NFA2016-05-15
00821684040331SpiderFXCovidien LPNFA2015-10-16
00821684040348SpiderFXCovidien LPNFA2015-10-16
00821684040355SpiderFXCovidien LPNFA2015-10-16
00821684040362SpiderFXCovidien LPNFA2015-10-16
00821684040379SpiderFXCovidien LPNFA2015-10-16
00821684040485SpiderFXCovidien LPNFA2015-10-16
00821684040492SpiderFXCovidien LPNFA2015-10-16
00821684040508SpiderFXCovidien LPNFA2015-10-16
00821684040515SpiderFXCovidien LPNFA2015-10-16
00821684040522SpiderFXCovidien LPNFA2015-10-16