Zilver Flex ZFV6-35-80-7-140

GUDID 10827002237541

Zilver Flex 35 Vascular Stent

COOK IRELAND LTD

Peripheral artery stent, bare-metal

• Primary Device ID: 10827002237541
• NIH Device Record Key: 19fffa96-c4c5-47ef-a6f1-29de6b192d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zilver Flex
• Version Model Number: G23754
• Catalog Number: ZFV6-35-80-7-140
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry location.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002237544 [Primary]
GS1	10827002237541 [Package]; Contains: 00827002237544; Package: BX [1 Units]; In Commercial Distribution

FDA Product Code

• NIP: STENT, SUPERFICIAL FEMORAL ARTERY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-12
• Device Publish Date: 2025-12-04

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• 10827002611747: Zilver Flex 35 Vascular Stent
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• 10827002611723: Zilver Flex 35 Vascular Stent
• 10827002611716: Zilver Flex 35 Vascular Stent
• 10827002611709: Zilver Flex 35 Vascular Stent
• 10827002611693: Zilver Flex 35 Vascular Stent
• 10827002611686: Zilver Flex 35 Vascular Stent
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• 10827002183169: Zilver Flex 35 Vascular Stent