AccessGUDID - DEVICE: SeeLuma (04064434000117)

GUDID

Device Identifier (DI) Information

Brand Name: SeeLuma
Version or Model: V10760-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Munich Surgical Imaging GmbH

Primary DI Number: 04064434000117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315155571 *Terms of Use

Device Description: The ophthalmic microscope is a surgical microscope designed for the illumination and magnification of the surgical area in ophthalmic surgeries.

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?
64676	Ophthalmic surgical microscope	An electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 1830 Millimeter
Depth: 840 Millimeter
Height: 1965 Millimeter

Device Record Status

Public Device Record Key: 877018e9-5396-43cf-bae9-aa674efdbb0c
Public Version Date: April 03, 2023
Public Version Number: 1
DI Record Publish Date: March 24, 2023