What is FDA product code OCT?

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

Vygon · Anti Fog Solution and Accessories, Endoscopy → Gastroenterology & Urology

Name: Vygon
Brand: Vygon

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Vygon
Listed by	Mectra Labs, Inc., 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	2019-01-24
Record revised	2020-01-13 (version 2)

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	Handling environment temperature 20 to 115 °F
Packaging	Case of 25, inner pack of 20
Distribution end date	2020-01-10

Catalogue Numbers

Catalogue numbers for Vygon
Catalogue number	Size	Status
0600-8331-000		Withdrawn

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
K993604	2000-03-03

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.

Vygon