AccessGUDID - DEVICE: OCT Ophthalmoscope (05057056107004)

GUDID

Device Identifier (DI) Information

Brand Name: OCT Ophthalmoscope
Version or Model: P200TE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A10700
Company Name: OPTOS PUBLIC LIMITED COMPANY

Primary DI Number: 05057056107004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346013337 *Terms of Use

Device Description: The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc. The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions. It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps. The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

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:	Yes
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?
64004	Scanning-laser ophthalmoscope/retinal optical coherence tomography system	An ophthalmic digital image capturing/processing device that is a combination of a scanning-laser ophthalmic imaging system and a retinal optical coherence tomography system intended to: 1) use a low power laser to generate and capture digital confocal images, 2) use a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement, of the retina and associated structures to diagnose and manage retinal diseases. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MYC	Ophthalmoscope,Laser,Scanning
OBO	Tomography, Optical Coherence

FDA Premarket Submission

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

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: 1ae8c9de-f4c7-444b-9ba6-61365832f161
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: April 02, 2018