ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 15060356150400
• Version / Model: ORLocate Gauze
• Catalog Number: GTS0804X1610
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-10-31
• Public Version: 2
• Public Version Date: 2023-03-14
• Public Version Status: Update
• Public Device Record Key: abe8b02a-9e0c-4428-b391-9fe8642ea61b
• Distribution End Date: 2023-03-13

Device Description

ORLocate RFID Gauze 16-ply 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1
GDY	Gauze/sponge, internal, x-ray detectable	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55060356150408	GS1	Case	80	Not in Commercial Distribution	2023-03-13
Primary	15060356150400	GS1
Unit of Use	05060356150403	GS1

Customer Contacts

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