AVRA 3-PC SECTION 3IN STERIS 5085

Basic Information

• Brand Name: AVRA 3-PC SECTION 3IN STERIS 5085
• Primary DI: 00842430110627
• Version / Model: 6950853AVS
• Catalog Number: 6950853AVS
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: d4a60499-0129-4a8f-b4ad-63a438acffd0
• Distribution End Date: 2024-01-26

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65164	Operating table mattress, pressure-sensing	An electrically-powered cushioned mattress with pressure-sensing properties designed to be placed on top of an operating table to serve as the surface upon which the patient is placed, and to map the patient’s body pressure distribution on its surface during a surgical procedure; the gathered data is transmitted to a pressure monitoring hub/tablet for analysis and display. The device is constructed with a pressure-sensitive fabric and is available in pads of different lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430110627	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]