FDA.reportPublic FDA data

Amplatz

Primary DI
00827002033771
Brand
Amplatz
Company
COOK INCORPORATED
Model
G03377
Catalog number
THSCF-35-145-7.5-AES
Device description
Amplatz Extra Stiff Wire Guide
Published
2016-09-24
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
DQXWIRE, GUIDE, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002033771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002033771008270020337718270020337710827002033771

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

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
Premarket exempt
true
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
10816349013536GuideRightLake Region MedicalDQX2026-03-24
10816349013543GuideRightLake Region MedicalDQX2026-03-24
10816349013550GuideRightLake Region MedicalDQX2026-03-24
10816349013567GuideRightLake Region MedicalDQX2026-03-24
10816349013574GuideRightLake Region MedicalDQX2026-03-24
10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
10816349013604GuideRightLake Region MedicalDQX2026-03-24
10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
16936733736408ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736415ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736644ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736651ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736668ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
06936733736678ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736965ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736996ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737009ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737085ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27