Flo-Rester® Disposable Internal Vessel Occluder 50225

GUDID 50085412531958

Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs on the distal ends of a flexible shaft. A tab on a tether is attached to the midpoint of the flexible shaft forming a T configuration. Flo-Rester bulbs and tab are radiopaque.

SYNOVIS LIFE TECHNOLOGIES, INC.

Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder Intravascular anastomosis occluder

• Primary Device ID: 50085412531958
• NIH Device Record Key: 0dba1f89-ad39-42f2-b870-4d49b14a2f86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flo-Rester® Disposable Internal Vessel Occluder
• Version Model Number: 50225
• Catalog Number: 50225
• Company DUNS: 017415781
• Company Name: SYNOVIS LIFE TECHNOLOGIES, INC.
• 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: false
• 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(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412531953 [Primary]
GS1	50085412531958 [Package]; Contains: 00085412531953; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883696

FDA Product Code

• DXC: CLAMP, VASCULAR

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: 2016-09-24

On-Brand Devices [Flo-Rester® Disposable Internal Vessel Occluder]

• 50085412532153: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532146: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532139: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532122: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532115: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532108: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532092: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532085: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532078: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532061: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532054: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532047: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532016: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412532009: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531996: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531989: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531972: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531965: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531958: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531941: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531934: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531927: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531910: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o
• 50085412531903: Flo-Rester is a sterile, single use, disposable occluder composed of two silicone rubber bulbs o