ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 05060356150205
• Version / Model: ORLocate Locator
• Catalog Number: OX202
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-07
• Public Version: 2
• Public Version Date: 2023-03-14
• Public Version Status: Update
• Public Device Record Key: 127fcd0d-eaa9-4981-9e9f-a9c27a122d6b
• Distribution End Date: 2023-03-13

Device Description

OrLocate Locator is a component to 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
63219	Radio-frequency identification reader	An electronic device designed to read information stored on radio-frequency identification (RFID) tags within its read range, typically to identify and track medical devices. The reader may be of the passive (receives data only) or active (transmits and receives data) type, and may have the capability of storing and/or transmitting the read data.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060356150205	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100551	000