FDA.reportPublic FDA data

Zilver PTX

Primary DI
10827002384634
Brand
Zilver PTX
Company
COOK IRELAND LTD
Model
G38463
Catalog number
ZISV6-35-125-6-40-PTX
Device description
Zilver PTX, Drug-Eluting Peripheral Stent
Published
2016-01-28
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
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
10827002384634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700238463410827002384634

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in 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