GRAFT SIZERS

GUDID 00384401513032

Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box of 10 units) with the catalog number M002363200201.

INTERVASCULAR SAS

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: 00384401513032
• NIH Device Record Key: 1c086bcf-5c67-43aa-a791-dd5f1cfa9217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFT SIZERS
• Version Model Number: Size 05 mm - 24 mm
• Company DUNS: 382174019
• Company Name: INTERVASCULAR SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com

Device Dimensions

• 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 at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384401016502 [Primary]
GS1	00384401513032 [Package]; Contains: 00384401016502; Package: Multipack Box of 10 [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854431

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-24

On-Brand Devices [GRAFT SIZERS]

• 00384401513049: Graft Sizers size 24 mm - 38 mm are commercially available only in Multipack configuration (box
• 00384401513032: Graft Sizers size 05 mm - 24 mm are commercially available only in Multipack configuration (box