NA

Basic Information

• Brand Name: NA
• Primary DI: 04048551432518
• Version / Model: TH004
• Catalog Number: TH004
• 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: 2025-03-28
• Public Version: 1
• Public Version Date: 2025-04-07
• Public Version Status: New
• Public Device Record Key: 94efc71f-7e43-4613-86bc-017263ffe230

Device Description

Micromanipulator Interface VITOM 3D

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: 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: 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
60490	Video camera surgical microscope system	An assembly of noninvasive devices intended to transmit detailed, magnified, video images from a surgical site (non-specific) to a monitor to facilitate visualization of the surgical site by the surgeon; it may include recording equipment for teaching applications. It typically includes a fibreoptic telescope, illumination hardware, video camera, positioning arm, appropriate hardware/cabling, and may include recording unit, monitor and transportation cart.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551432518	GS1

Customer Contacts

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