Flo-Rester® Disposable Internal Vessel Occluder

FDA UDI

Class II (US FDA UDI)

by Synovis Life Technologies, Inc.

Identity

Trade Name: Flo-Rester® Disposable Internal Vessel Occluder FDA UDI
Generic Name: Intravascular anastomosis occluder FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 60275 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 60275 FDA UDI
Primary DI / UDI-DI: 00085412532110 FDA UDI
510(k) Number: K883696 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Intravascular anastomosis occluder FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Intravascular anastomosis occluder

Flo-Rester® Disposable Internal Vessel Occluder by Synovis Life Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K883696 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Synovis Life Technologies, Inc.

Sources (1)

FDA UDI ce203edc-b9cd-4612-b60e-3014bdbab58e 36 fields · synced Jun 6, 2026