PRO-LITE

Basic Information

• Brand Name: PRO-LITE
• Primary DI: 00724995204181
• Version / Model: VP0077
• Catalog Number: VP0077
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-23
• Public Version: 3
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 3023f579-885f-4481-a32d-bd2429524705

Device Description

The PRO-Lite Sterilization Tray Mat, 12-inch x 11.75-inch, is used in V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KCT	Sterilization wrap containers, trays, cassettes & other accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	00724995003005	GS1
Primary	00724995204181	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160912	000
K172755	000
K183301	000
K183402	000
K222440	000
K231501	000

Device Sizes

Type	Value	Unit	Text
Width	12	Inch
Length	12	Inch