VITOM

Basic Information

• Brand Name: VITOM
• Primary DI: 04048551324738
• Version / Model: 20916025DA
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-23
• Public Version: 3
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: 2d73bc90-b56e-4c5f-a450-6b7ad30763d0

Device Description

VITOM® Tel. 90° w Integ. Illuminator

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EPT	MICROSCOPE, SURGICAL	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60491	Surgical microscope video camera, sterilizable	An optical device intended to be used as part of a video camera surgical microscope system to send magnified images of a surgical site, via a camera and appropriate hardware, to a monitor to facilitate visualization of the surgical site by the surgeon or for teaching applications. It is typically a housing containing a distal lens, fibreoptic cabling, and an illumination port. It is intended to be fixed (using a positioning arm) at an appropriate distance from the surgical site (e.g., 25-75cm), and is not intended to contact the patient. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551324738	GS1