ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 10724995221673
• Version / Model: ORLocate Drape
• Catalog Number: LC16961NS
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 1
• Public Version Date: 2023-05-15
• Public Version Status: New
• Public Device Record Key: 7d0a17a1-3fbf-455f-b216-3447433f1475

Device Description

ORLocate Locator Drape with three straps, non-sterile is used with the ORLocate Sponge Solution System.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
PUI	Drape, surgical, exempt	General, Plastic Surgery	878.4370	2

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
Package	50724995221671	GS1	Box	10	In Commercial Distribution
Primary	10724995221673	GS1
Unit of Use	00724995221676	GS1
Previous	15060356150059	GS1

Customer Contacts

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