ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 10724995220126
• Version / Model: ORLocate Lap Sponge
• Catalog Number: LTS1818X45
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-03-14
• Public Version: 1
• Public Version Date: 2023-03-22
• Public Version Status: New
• Public Device Record Key: 80e80796-d3e2-4737-8fe4-2bf54b2191fe

Device Description

ORLocate RFID Gauze Lap Sponge 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDY	Gauze/sponge, internal, x-ray detectable	General, Plastic Surgery	878.4450	1
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	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
Package	50724995220124	GS1	Case	40	In Commercial Distribution
Primary	10724995220126	GS1
Unit of Use	00724995220129	GS1
Previous	15060356150073	GS1

Customer Contacts

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