NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207011591
• Version / Model: 896002
• Catalog Number: 8960.02
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: aeb87830-ade3-42d5-a41e-1fb40cff3b55
• Distribution End Date: 2018-06-15

Device Description

MEDIASTINOSCOPE WL 140MM model Freiburg, outer dimension Ø 26mm, TL 198mm, with integrated light carrier, reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCH	MEDIASTINOSCOPE, DIAGNOSTIC	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35187	Rigid optical mediastinoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207011591	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	140	Millimeter