Cleaners, Medical Devices

Device Code: 2672

Product Code(s): MDZ

Device Classification Information

• Device Type ID: 2672
• Device Name: Cleaners, Medical Devices
• Regulation Description: Medical Washer-disinfector.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.6992 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MDZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2672
• Device: Cleaners, Medical Devices
• Product Code: MDZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Medical Washer-disinfector.
• CFR Regulation Number: 880.6992 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Apr-30-2015

TPLC Last Update: 2019-04-02 20:17:11