Burr, Corneal, Battery Powered, Rust Ring Removal
Ophthalmic · 21 CFR 886.4070
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
23 firms currently registered for this product code
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Phoenix Instruments, Inc.
Lisle, IL, US
The Alger Company, Inc.
Lago Vista, TX, US
Bgs Beta-gamma-service Gmbh & Co Kg
Bruchsal Baden-Wurttemberg, DE
Mibo Medical Group
Irving, TX, US
Rumex International Co.
Tampa, FL, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Shenzhen Jpy Ion-tech. Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Jie Zhong Lian Technology Co., Ltd.
Shenzhen Guangdong, CN
Med Saver, Inc.
PHOENIXVILLE, PA, US
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Katena Products, Inc.
Randolph, NJ, US
Microsurgical Technology, Inc.
Redmond, WA, US
Katena Products, Inc.
Parsippany, NJ, US
Shenzhen Create Technology Co.,ltd
Shenzhen Guangdong, CN
Gebr. Brasseler Gmbh & Co. Kg
LEMGO North Rhine-Westphalia, DE
Speedway
India Delhi, IN
Novo Surgical, Inc.
Westmont, IL, US
Huizhou Foryou Medical Devices Co.,ltd.
HuiZhou Guangdong, CN
Stephens Instruments, Inc
LEXINGTON, KY, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Ambler Surgical, Llc
EXTON, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.