FDA.reportPublic FDA data

Zilver Flex

Primary DI
10827002183121
Brand
Zilver Flex
Company
COOK IRELAND LTD
Model
G18312
Catalog number
ZFV6-35-125-9-40
Device description
Zilver Flex 35 Vascular Stent
Published
2025-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIPStent, Superficial Femoral ArteryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002183121PackageGS11In Commercial Distribution
00827002183124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700218312110827002183121
00827002183124008270021831248270021831240827002183124

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the device in a dry location.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
988559035
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00827002037960Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037977Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002037991Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038004Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038011Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002038028Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182370Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182387Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182394Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182417Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182431Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182448Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182455Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182462Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182479Zilver FlexCOOK IRELAND LTDNIP2025-12-04
00827002182493Zilver FlexCOOK IRELAND LTDNIP2025-12-04
20705032082331S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082362S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082379S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082386S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082409S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082423S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082447S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082485S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082508S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082553S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
20705032082584S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082614S.M.A.R.T. RADIANZCordis US Corp.NIP2022-04-15
20705032082652S.M.A.R.T. RADIANZCORDIS CORPORATIONNIP2022-04-15
00733132645725GORE VIABAHN EndoprosthesisW. L. Gore & Associates, Inc.NIP2019-08-16