Olympus

Basic Information

• Brand Name: Olympus
• Primary DI: 04042761083560
• Version / Model: WA90004W
• Catalog Number: WA90004W
• Company Name: OLYMPUS Winter & Ibe GmbH
• Labeler DUNS: 316957240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-31
• Public Version: 2
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 39924aa2-3ff4-408e-9890-9e5a127d29ec

Device Description

Argon Plasma Coagulation unit APU-300

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36154	Argon-enhanced electrosurgical system gas delivery unit	A device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04042761083560	GS1

Customer Contacts

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