ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147000261
• Version / Model: 10150-000
• Catalog Number: 10150-000
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2024-02-07
• Public Version Status: Update
• Public Device Record Key: d7408454-0f0f-4f1c-9096-fe1fd4d31b7b

Device Description

ERBEJET® 2 Hydrosurgical Unit

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
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36961	Water jet knife system generator	A mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050147000261	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072404	000
K143306	000
K231023	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -25 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat and direct sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -25 – 50 Degrees Celsius