Zenith ZFEN-P-1-24-91-R

GUDID 10827002325071

Zenith Fenestrated, AAA Endovascular Graft, Proximal Body

WILLIAM A. COOK AUSTRALIA PTY. LTD.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 10827002325071
• NIH Device Record Key: cd97ab0e-1249-4951-b5fa-44b99ea27c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zenith
• Version Model Number: G32507
• Catalog Number: ZFEN-P-1-24-91-R
• Company DUNS: 758568000
• Company Name: WILLIAM A. COOK AUSTRALIA PTY. 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10827002325071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020018

FDA Product Code

• MIH: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2014-09-24

On-Brand Devices [Zenith]

• 10827002325927: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325910: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325903: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325897: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325880: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325873: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325866: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325859: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325842: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325835: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325828: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325811: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325804: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325798: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325781: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325774: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325767: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325750: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325743: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325736: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325729: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325712: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325705: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325699: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325682: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325675: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325668: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325651: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325644: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325637: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325620: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325613: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325606: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325590: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325583: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325576: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325569: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325552: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325545: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325538: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325521: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325514: Zenith Fenestrated, AAA Endovascular Graft, Distal Body
• 10827002325507: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325491: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325484: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325477: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325460: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325453: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325446: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
• 10827002325439: Zenith Fenestrated, AAA Endovascular Graft, Proximal Body