SMARTSCREEN

Basic Information

• Brand Name: SMARTSCREEN
• Primary DI: 04048551418147
• Version / Model: WM200
• 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: 2020-03-02
• Public Version: 1
• Public Version Date: 2020-03-10
• Public Version Status: New
• Public Device Record Key: 7df791be-c684-4d63-81ff-872bd51c3e5f

Device Description

OR1 SmartScreen

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMD	System, digital image communications, radiological	Radiology	892.2020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18101	Physician-practice-management information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data to support the administrative and clinical activities associated with the provision and utilization of physician services and office facilities. The system may be used to process insurance claims [e.g., for generation, electronic data interchange (EDI), referrals], prepare patient statements, schedule the physician's time, make patient appointments, and store and retrieve patient records. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551418147	GS1