FDA.report

Zilver Vena

Primary DI
10827002574301
Brand
Zilver Vena
Company
COOK IRELAND LTD
Model
G57430
Catalog number
ZVT7-35-80-10-100
Device description
Zilver Vena, Venous Self-Expanding Stent
Published
2020-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QANStent, iliac vein

Product Code Classifications

CodeDeviceSpecialtyClass
QANStent, Iliac VeinUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10827002574301PrimaryGS10

GMDN Terms

TermDefinition
Iliofemoral vein stentA non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Do not store outside the temperature range of 2 Degrees C to 40 Degrees C (36 Degrees F to 104 Degrees F). Store in a dark, dry, cool place. Avoid extended exposure to light.
Storage Environment Temperature2 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

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 DIBrandModelCatalogPublished
10827002256702SolusG25670ZSS-10-3-RB2015-10-24
10827002256719SolusG25671ZSS-10-4-RB2015-10-24
10827002256726SolusG25672ZSS-10-5-RB2015-10-24
10827002256733SolusG25673ZSS-10-7-RB2015-10-24
10827002256740SolusG25674ZSS-10-9-RB2015-10-24
10827002256757SolusG25675ZSS-10-12-RB2015-10-24
10827002256764SolusG25676ZSS-10-15-RB2015-10-24
10827002256856SolusG25685ZSS-10-10-RB2015-10-24
10827002268293SolusG26829ZSS-10-1-RB2015-10-24
10827002496559Cotton-Leung Sof-FlexG49655CLSO-SF-10-92015-11-03
10827002496566Cotton-Leung Sof-FlexG49656CLSO-SF-10-122015-11-03
10827002496580Cotton-Leung Sof-FlexG49658CLSO-SF-7-52015-11-03
10827002496597Cotton-Leung Sof-FlexG49659CLSO-SF-7-72015-11-03
10827002496610Cotton-Leung Sof-FlexG49661CLSO-SF-7-122015-11-03
10827002496627Cotton-Leung Sof-FlexG49662CLSO-SF-7-152015-11-03
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03
10827002496665Geenen Sof-FlexG49666GPSO-SF-5-92015-11-03
10827002496672Geenen Sof-FlexG49667GPSO-SF-5-122015-11-03
10827002496719Geenen Sof-FlexG49671GPSOS-SF-5-92015-11-03
10827002496726Geenen Sof-FlexG49672GPSOS-SF-5-122015-11-03

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10827002574295Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574318Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574325Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574332Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574349Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574356Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574363Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574370Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574387Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574394Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574400Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574417Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574424Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574431Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574448Zilver VenaCOOK IRELAND LTDQAN2020-11-04
10827002574455Zilver VenaCOOK IRELAND LTDQAN2020-11-04