ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147021815
• Version / Model: 20402-410
• Catalog Number: 20402-410
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 2
• Public Version Date: 2021-11-01
• Public Version Status: Update
• Public Device Record Key: a2c9a624-f041-4b1e-b33b-1d40979e4efa

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
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64409	Endoscopic cryosurgical probe, single-use	A flexible distal component of a cryosurgical system intended to be inserted through the working channel of an endoscope for cryoadhesion and devitalization of tissues during interventional procedures (e.g., bronchoscopy/interventional pulmonology). It is connected at the proximal end to the system control unit whereby gas expansion within the probe tip causes cooling of the tip based on the Joule-Thompson effect. It is typically intended for a variety of surgical applications (e.g., biopsy, recanalization, removal of blood clots). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04050147021822	GS1	Level 1	5	In Commercial Distribution
Primary	04050147021815	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190651	000

Device Sizes

Type	Value	Unit	Text
Length	1150	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat and direct sunlight
• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity