Erbe

Basic Information

• Brand Name: Erbe
• Primary DI: 04050147023826
• Version / Model: 20150-120
• Catalog Number: 20150-120
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-01
• Public Version: 1
• Public Version Date: 2026-04-09
• Public Version Status: New
• Public Device Record Key: f4fa0755-1094-441d-a71a-da42d2dd3ae9

Device Description

MOVIVA®; Ø 2,4mm; L 1,9m

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
FQH	Lavage, Jet	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62227	Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument	A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by gas plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to a parent device (i.e., inert gas-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include controls. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04050147023833	GS1		5	In Commercial Distribution
Primary	04050147023826	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K253915	000

Device Sizes

Type	Value	Unit	Text
Length	1.9	Meter

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
• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity