ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 00724995220679
• Version / Model: ORLocate Tablet
• Catalog Number: OX216
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 51f89f00-d839-486b-ba46-ea41aee63070

Device Description

Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Lot/Batch Number: No
• 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
LWH	Counter, sponge, surgical	General Hospital	880.2740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61906	Electronic surgical sponge-counter	A hand-held battery-powered computerized device intended to be used in the operating room (OR) by professional staff to electronically maintain the count of surgical sponges/swabbing materials during a surgical procedure to prevent swabs from being inadvertently left in a patient. It typically has controls/keyboard, display and built-in bar-code reader, whereby packs of surgical sponges entering the surgical field are intended to be scanned in and counted out. It may include device for battery recharging or connection to a personal computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995220679	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100551	000