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-02-0530 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-02-0530 FDA UDI
Primary DI / UDI-DI: 00815128020355 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 — 8 Millimeter FDA UDI
Lumen/Inner Diameter — 5 Millimeter FDA UDI

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

The FloShield/Plus System is a single-use, disposable laparoscopic accessory device designed to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery. It is intended for use in conjunction with commercially available laparoscopes and endoscopes, providing a sterile environment for surgical procedures.

Similar devices

Also classified as Endoscope lens cleaner, gas/fluid, single-use.

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InstaClear — Gyrus Acmi, Inc. · Class II
CS-05-30-300 OpClear Disposable — Cipher Surgical, Ltd. · Class II
CS-10-00-330 OpClear Disposable — Cipher Surgical, Ltd. · Class II
InstaClear — Gyrus Acmi, Inc. · Class II
InstaClear — Gyrus Acmi, Inc. · Class II
CS-CU15-03 OpClear Control Unit — Cipher Surgical, Ltd. · Class II

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 4a35e484-f3cf-4c41-84e3-7a5f2219a5f8 37 fields · synced Jun 28, 2026