Graft Sizer Set GSS002

GUDID 05037881038902

Graft Sizer Set

VASCUTEK LTD

Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery vascular sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use Open-surgery blood vessel sizer, single-use

• Primary Device ID: 05037881038902
• NIH Device Record Key: 14542861-a699-4706-b49a-f17e408a2b5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graft Sizer Set
• Version Model Number: GSS002
• Catalog Number: GSS002
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)888-3786
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean dry enviroment at normal room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881038902 [Package]; Contains: 05037881038919; Package: [10 Units]; In Commercial Distribution
GS1	05037881038919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955588

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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: 2020-03-24
• Device Publish Date: 2016-09-21

Devices Manufactured by VASCUTEK LTD

• 05037881160702 - Vascutek Gelweave™ Vascular Grafts: 2023-09-08 Vascutek Gelweave™ Vascular Grafts
• 05037881160726 - Vascutek Gelweave™ Vascular Grafts: 2023-09-08 Vascutek Gelweave™ Vascular Grafts
• 05037881160733 - Vascutek Gelweave™ Vascular Grafts: 2023-09-08 Vascutek Gelweave™ Vascular Grafts
• 05037881160740 - Vascutek Gelweave™ Vascular Grafts: 2023-09-08 Vascutek Gelweave™ Vascular Grafts
• 05037881160757 - Vascutek Gelweave™ Vascular Grafts: 2023-09-08 Vascutek Gelweave™ Vascular Grafts
• 05037881026626 - Thoraflex™ Hybrid: 2022-06-08 Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026695 - Thoraflex™ Hybrid: 2022-06-08 Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026701 - Thoraflex™ Hybrid: 2022-06-08 Thoraflex Hybrid Plexus 4 Hybrid Stent Device