Erbe

Basic Information

• Brand Name: Erbe
• Primary DI: 04050147022751
• Version / Model: 20220-100
• Catalog Number: 20220-100
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 1
• Public Version Date: 2025-01-29
• Public Version Status: New
• Public Device Record Key: 80ff1904-34d2-445e-96c6-9e679cd45d42

Device Description

HybridTherm® bipolar; ø 1,9mm; L 1,25m

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: No
• 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
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2
JOS	Electrode, Electrosurgical	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57944	Endoscopic electrosurgical handpiece/electrode, bipolar, single-use	A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050147022751	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240932	000

Device Sizes

Type	Value	Unit	Text
Length	1250	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat and direct sunlight