What is FDA product code OCT?

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Gastroenterology & Urology › DiagnosticAnti Fog Solution And Accessories, Endoscopy

FloShield/Plus

Name: FloShield/Plus
Brand: FloShield/Plus

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…

Registry build 21.09.26

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.

5manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OCT
Manufacturer	City	Province	Registered as	Device types
Jianerkang Medical Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	18
Shenzhen Jingxintai Houseware Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Shanghai Xodus Medical Company Limited	Shanghai	Shanghai	Specification developer	25
Shanghai Lejoy Co., Ltd.	Shanghai	Shanghai	Exporter	21
Changzhou Atomic HI-Tech Radiation Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	8

Record

Regulatory record for FloShield/Plus
Listed by	Minimally Invasive Devices, LLC, United States
FDA product code	OCT
Device type	Anti Fog Solution And Accessories, Endoscopy
Device class	Class 2
Regulation	21 CFR 876.1500
Record published	2016-07-25
Record revised	2019-04-09 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 115 °F
Packaging	Sales box of 6
Sizes	Outer diameter 12 mm; lumen/inner diameter 10 mm

Catalogue Numbers

Catalogue numbers for FloShield/Plus
Catalogue number	Size	Status
FSB-04-1045	Outer Diameter 12 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mr. Clear Purple	Mectra Labs, Inc.	8
DeRoyal	Deroyal Industries, Inc.	7
Dr. Fog® Treated Sponge	Aspen Surgical Products, Inc.	4
Dr. Fog® Solution With Sponge	Aspen Surgical Products, Inc.	2
Merocel® Elvis®	Medtronic Xomed, Inc.	2
Aspen® Anti-fog Solution	Aspen Surgical Products, Inc.	2
Dr. Fog® Anti-fog Solution	Aspen Surgical Products, Inc.	2
Richard Wolf	Mectra Labs, Inc.	2
Anti-fog w/Pad	Xodus Medical, Inc.	2
Merocel®	Medtronic Xomed, Inc.	2
Cardinal Health	Cardinal Health 200, LLC	2
Anti-Fog w/ Pad; in Tray	Xodus Medical, Inc.	2

Showing 12 of 41. All products under Anti Fog Solution And Accessories, Endoscopy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K102452	2010-12-23
K080613	2008-11-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.