ERBE

Basic Information

• Brand Name: ERBE
• Primary DI: 04050147008038
• Version / Model: 20416-036
• Catalog Number: 20416-036
• Company Name: Erbe Elektromedizin GmbH
• Labeler DUNS: 316116623
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 4fc5b70c-9a57-4f81-a91b-4a9cfdfa3107

Device Description

Flexible cryo probe; for USA OD 1.9mm; L 900mm

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
62328	Endoscopic cryosurgical probe, reusable	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 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050147008038	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051509	000

Device Sizes

Type	Value	Unit	Text
Length	900.000	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