AccessGUDID - DEVICE: Retina Workplace (04049471070118)

GUDID

Device Identifier (DI) Information

Brand Name: Retina Workplace
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049471070118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314594680 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFJ	System, Image Management, Ophthalmic
HKI	Camera, Ophthalmic, Ac-Powered
OBO	Tomography, Optical Coherence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150467	000
K170638	000
K182318	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e46670db-c0aa-445b-b05d-7f630abb0ab1
Public Version Date: November 08, 2019
Public Version Number: 5
DI Record Publish Date: September 16, 2016