Olympus

Basic Information

• Brand Name: Olympus
• Primary DI: 14042761083437
• Version / Model: WA94003A
• Catalog Number: WA94003A
• Company Name: OLYMPUS Winter & Ibe GmbH
• Labeler DUNS: 316957240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-07-31
• Public Version: 3
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: b66e3320-83e9-45c7-a524-f422946718b1

Device Description

Single Use Plasma Coagulation Probe Axial Argon PA-212U 3.2 x 2200 mm

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61878	Inert gas-enhanced endoscopic electrosurgical electrode, single-use	An invasive, distal component of an inert gas-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04042761083430	GS1
Primary	14042761083437	GS1

Customer Contacts

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