What is FDA product code OCT?

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

Gastroenterology & Urology › DiagnosticAnti Fog Solution And Accessories, Endoscopy

Dr. Fog® Treated Sponge

Name: Dr. Fog® Treated Sponge
Brand: Dr. Fog® Treated Sponge

4 catalogue numbers from DF-3120B, listed by Aspen Surgical Products, Inc., United States, under Anti Fog Solution And Accessories, Endoscopy. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

4catalogue numbers in this listing

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 Dr. Fog® Treated Sponge
Listed by	Aspen Surgical Products, Inc., United States
FDA product code	OCT
Device type	Anti Fog Solution And Accessories, Endoscopy
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K932449
Record published	2021-02-25
Record revised	2023-01-20 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Packaging	Pack of 12, pack of 50, pack of 20, pack of 2

Catalogue Numbers

Catalogue numbers for Dr. Fog® Treated Sponge
Catalogue number	Size	Status
DF-3120B		In distribution
DF-3120B		In distribution
DF-3120		In distribution
DF-3120		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® 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
Key Surgical Mr. Clear Anti-Fog	Key Surgical, LLC	1

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

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.