FDA.reportPublic FDA data

Zilver PTX

Primary DI
10827002249162
Brand
Zilver PTX
Company
COOK IRELAND LTD
Model
G24916
Catalog number
ZIV6-35-125-8-80-PTX
Device description
Zilver PTX, Drug-Eluting Peripheral Stent
Published
2014-12-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIUStent, superficial femoral artery, drug-eluting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIUStent, Superficial Femoral Artery, Drug-ElutingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002249162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700224916210827002249162

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting femoral artery stentA non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted, via a delivery catheter, into the superficial femoral artery to maintain luminal patency typically in patients with symptomatic peripheral artery disease. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark, dry, cool place. Avoid extended exposure to light.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
988559035
Device count
1
Combination product
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
00827002315181EchoTipG31518ECHO-1-222016-09-24
00827002315198EchoTipG31519ECHO-252016-09-24
00827002315204EchoTipG31520ECHO-192016-09-24
00827002347854EchoTip ProCoreG34785ECHO-HD-3-20-C2016-09-24
00827002535855EchoTip ProCoreG53585ECHO-HD-19-C2016-09-24
00827002557369EchoTip ProCoreG55736ECHO-HD-22-C2016-09-24
00827002557383EchoTip ProCoreG55738ECHO-HD-25-C2016-09-24
00827002491427Fusion MarathonG49142FS-MAR-10-52015-10-24
10827002256948JohlinG25694JPWS-8.5-82015-10-24
10827002256955JohlinG25695JPWS-8.5-102015-10-24
10827002257136JohlinG25713JPWS-10-82015-10-24
10827002257143JohlinG25714JPWS-10-102015-10-24
10827002257150JohlinG25715JPWS-10-122015-10-24
10827002257167JohlinG25716JPWS-10-142015-10-24
00827002214392ZimmonG21439ZEBD-11.5-52015-10-24
00827002214422ZimmonG21442ZEBD-11.5-72015-10-24
00827002214460ZimmonG21446ZEBD-11.5-92015-10-24
00827002222076ZimmonG22207ZEBD-11.5-122015-10-24
00827002224421ZimmonG22442ZEBD-11.5-152015-10-24
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729876564ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
08714729876625ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
08714729876687ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
08714729876748ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2022-07-15
10827002384047Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384078Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384085Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384146Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384153Zilver PTXCOOK IRELAND LTDNIU2018-12-13
10827002384160Zilver PTXCOOK IRELAND LTDNIU2018-12-13
08714729876519ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876526ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876533ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876540ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876557ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876571ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876588ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876595ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876601ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876618ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876632ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876649ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876656ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876663ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876670ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876694ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876700ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876717ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876724ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10
08714729876731ELUVIA™BOSTON SCIENTIFIC CORPORATIONNIU2018-10-10