ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147000902
• Version / Model: 20132-113
• Catalog Number: 20132-113
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-30
• Public Version: 3
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: e9be535e-35bf-40d8-803b-79111aa59fca

Device Description

APC-applicator 300 A, rigid, OD: 2.3 mm, L: 300 mm

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
61879	Inert gas-enhanced open-surgery electrosurgical electrode, reusable	A rigid, invasive, distal component of an inert gas-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050147000902	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	300.000	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat and direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry