What is FDA product code OHW?

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.

Ophthalmic › SurgicalBurr, Corneal, Battery Powered, Rust Ring Removal

Algerbrush Corn Rust Ring REM 0.5MM Burr

Name: Algerbrush Corn Rust Ring REM 0.5MM Burr
Brand: Algerbrush Corn Rust Ring REM 0.5MM Burr

Catalogue number AE-3250, listed by Katena Products, Inc., United States, under Burr, Corneal, Battery Powered, Rust Ring Removal. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OHW
Manufacturer	City	Province	Registered as	Device types
Huizhou Foryou Medical Devices Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	18
Shenzhen JPY ION-Tech. Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20
Shenzhen Jie Zhong Lian Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	17
Shenzhen Create Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	9

Record

Regulatory record for Algerbrush Corn Rust Ring REM 0.5MM Burr
Listed by	Katena Products, Inc., United States
FDA product code	OHW
Device type	Burr, Corneal, Battery Powered, Rust Ring Removal
Device class	Class 1
Regulation	21 CFR 886.4070
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2022-12-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Algerbrush Corn Rust Ring REM 0.5MM Burr
Catalogue number	Size	Status
AE-3250		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MSI Precision Specialty Instruments	MED Saver, Inc.	25
Burr	Katena Products, Inc.	10
Wexler Surgical, Inc.	Wexler Surgical, Inc.	6
Algerbrush Diamond Burr	Sontec Instruments, Inc.	5
Algerbrush II	THE Alger Company, Inc.	2
Algerbrush Burr	Sontec Instruments, Inc.	2
Algerbrush II Corneal Rust Ring Remover	Sontec Instruments, Inc.	2
Algerbrush Rust Ring REM CHUCK.5MM Burr	Katena Products, Inc.	1
Algerbrush II Pterygium 3.5 RND MED Diam	Katena Products, Inc.	1
Yoshida Diamond Coated Burr	Katena Products, Inc.	1
Algerbrush Rust Ring REM Burr 0.5MM	Katena Products, Inc.	1
Algerbrush Corn Rust Ring REM Burr 1.0MM	Katena Products, Inc.	1

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.