FloShield/Plus

FDA UDI

Class II (US FDA UDI)

by Minimally Invasive Devices, LLC

Identity

Trade Name: FloShield/Plus FDA UDI
Generic Name: Endoscope lens cleaner, gas/fluid, single-use FDA UDI
Device Name: The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site. FDA UDI
Model / Reference: FSB-01-1000 FDA UDI
Description: The FloShield/Plus System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site. FDA UDI

Identifiers

Catalog Number: FSB-01-1000 FDA UDI
Primary DI / UDI-DI: 00815128020430 FDA UDI
FDA Product Code: GCJ FDA UDI
OCT FDA UDI
GMDN Term: Endoscope lens cleaner, gas/fluid, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Dimensions & Sizes

Size: Outer Diameter — 12 Millimeter FDA UDI
Lumen/Inner Diameter — 10 Millimeter FDA UDI

Category: Endoscope lens cleaner, gas/fluid, single-use

FloShield/Plus by Minimally Invasive Devices, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Minimally Invasive Devices, LLC

Sources (1)

FDA UDI 98d2ba50-1835-4fb7-bcca-b08d153bfc12 37 fields · synced May 30, 2026