FloShield/Air FSS-02-0545T

GUDID 00815128020072

The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and debris deflection during minimally-invasive surgery while maintaining visualization of the surgical site.

MINIMALLY INVASIVE DEVICES, INC.

Endoscope lens cleaner, gas/fluid, single-use
Primary Device ID00815128020072
NIH Device Record Key740a7a9d-2589-4482-9e39-9381d8fa82a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloShield/Air
Version Model NumberFSS-02-0545T
Catalog NumberFSS-02-0545T
Company DUNS793517660
Company NameMINIMALLY INVASIVE DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-614-340-3349
Emailinquiries@floshield.com
Phone1-614-340-3349
Emailinquiries@floshield.com

Device Dimensions

Lumen/Inner Diameter5 Millimeter
Lumen/Inner Diameter5 Millimeter
Lumen/Inner Diameter5 Millimeter
Lumen/Inner Diameter5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Fahrenheit and 115 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100815128020072 [Primary]
GS110815128020079 [Package]
Package: Sales Box [6 Units]
In Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-09
Device Publish Date2016-07-25

On-Brand Devices [FloShield/Air]

00815128020737The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020720The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020294The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020287The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020270The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020263The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020256The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020249The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020232The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020225The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020218The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020201The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020195The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020188The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020171The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020164The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020157The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020140The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
10815128020130The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020126The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
10815128020116The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020102The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020096The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020089The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020072The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020065The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020058The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
10815128020048The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020034The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
10815128020024The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
10815128020017The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
00815128020003The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended
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