Retina Workplace

Basic Information

• Brand Name: Retina Workplace
• Primary DI: 04049471070118
• Version / Model: 1.0
• Company Name: Carl Zeiss Meditec AG
• Labeler DUNS: 314594680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 5
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: e46670db-c0aa-445b-b05d-7f630abb0ab1

Device Description

This database entry covers UDI for SW Versions 1.0 and higher: (01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

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: No
• Has Lot/Batch Number: Yes
• 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
NFJ	System, Image Management, Ophthalmic	Radiology	892.2050	2
HKI	Camera, Ophthalmic, Ac-Powered	Ophthalmic	886.1120	2
OBO	Tomography, Optical Coherence	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44106	Patient health record information system application software	An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049471070118	GS1

Premarket Submissions

Submission Number	Supplement Number
K150467	000
K170638	000
K182318	000