Zilver 635 ZIV6-35-125-10-80

GUDID 10827002438436

Zilver 635 Vascular Stent

COOK IRELAND LTD

Iliac artery stent, bare-metal

• Primary Device ID: 10827002438436
• NIH Device Record Key: ee766f84-dbbf-4868-b1e5-4f38bf49ef2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zilver 635
• Version Model Number: G43843
• Catalog Number: ZIV6-35-125-10-80
• Company DUNS: 988559035
• Company Name: COOK IRELAND LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry, cool place. Avoid extended exposure to light.
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002438436 [Primary]

FDA Product Code

• NIO: STENT, ILIAC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-24

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