Zenith ZFEN-P-1-26-121-R

GUDID 10827002325187

Zenith Fenestrated, AAA Endovascular Graft, Proximal Body

WILLIAM A. COOK AUSTRALIA PTY. LTD.

Synthetic vascular graft

• Primary Device ID: 10827002325187
• NIH Device Record Key: 02c612af-db81-402d-8694-026e6415bdb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zenith
• Version Model Number: G32518
• Catalog Number: ZFEN-P-1-26-121-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	10827002325187 [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