AccessGUDID - DEVICE: 577nm Heine Omega 500 IO with integrated adaptor (03700542625392)

GUDID

Device Identifier (DI) Information

Brand Name: 577nm Heine Omega 500 IO with integrated adaptor
Version or Model: IOH577
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QUANTEL MEDICAL

Primary DI Number: 03700542625392
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 738574953 *Terms of Use

Device Description: 577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor

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):	No
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?
32729	Indirect binocular laser ophthalmoscope	An electrically-powered, head-worn, ophthalmic device used for the stereoscopic examination and laser treatment of the eye, particularly the retina. It typically consists of a headband, a built-in light with aperture control for adjustment of the illumination field, convergence controls to synchronize the illumination and examination beams, a delivery mirror, filters to protect the surgeon against incidental laser-beam reflection, and a power-supply cable for the lighting, and a fibreoptic cable to convey the laser beam. This device is connected to an appropriate laser for delivery of laser energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091581	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: 3f0f2079-892e-4a49-9692-9b34e0070152
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: September 23, 2016