AccessGUDID - DEVICE: Labomed Prima OPH microscope (Basic, motorized fine focus) (08908006463312)

GUDID

Device Identifier (DI) Information

Brand Name: Labomed Prima OPH microscope (Basic, motorized fine focus)
Version or Model: 6136000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LABOTECH MICROSCOPES INDIA PRIVATE LIMITED

Primary DI Number: 08908006463312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 919049606 *Terms of Use

Device Description: - MaxLite(TM) optics, 5 step magnification: 0.4x, 0.6x, 1.0x, 1.6x, 2.5x - RedReflex optical system - 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply - 45° inclined binocular head, IPD 55-75mm - f=200mm CMO - WF 10x/16mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (525mm Long, 360° rotation) and suspension arm (600mm Long, 320° rotation) with locking/tension control knobs and LED shut-off in park position - Z-Axis motorized fine focus - Floor stand with H-shape base on castor wheels with brakes - Blue and Green sliding filters, dust cover, and sterilizable knob caps

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 075d8792-d213-4a06-9ca6-1faefb6b76a1
Public Version Date: June 23, 2023
Public Version Number: 1
DI Record Publish Date: June 15, 2023