ORLocate

Basic Information

• Brand Name: ORLocate
• Primary DI: 10724995220157
• Version / Model: ORLocate Vaginal Packing
• Catalog Number: VAG4X36LPFLNS
• Company Name: Steris Corporation
• Labeler DUNS: 177360039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 240
• 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: bc869595-db49-4786-a738-cba24f9f9b33

Device Description

ORLocate RFID Vaginal Packing Loop and Fold 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
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
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	50724995220155	GS1	Case	2	In Commercial Distribution
Primary	10724995220157	GS1
Unit of Use	00724995220150	GS1
Previous	15060356150158	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	4	Inch
Length	36	Inch