AccessGUDID - DEVICE: OCT500 (03615020000489)

GUDID

Device Identifier (DI) Information

Brand Name: OCT500
Version or Model: OCT2JT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ESSILOR INTERNATIONAL

Primary DI Number: 03615020000489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 277373213 *Terms of Use

Device Description: 3D Optical Coherence Tomography OCT500 is a non-contact, high-resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging, and measurement of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, ganglion cell complex, macula, optic nerve head. It is also indicated for in-vivo viewing, axial cross-sectional and three dimensional imaging of anterior ocular structures, including the cornea. The instrument is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, agerelated macular degeneration, and glaucoma.

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?
46799	Retinal optical coherence tomography system	An assembly of devices that uses a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement of the retina, the retinal nerve fibre layer (its thickness), and optic disk in order to diagnose and manage retinal diseases. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional images of the retina or three-dimensional (3-D) volume scans. Optical coherence tomography (OCT) is used for visualizing the area/location of retinal-thickness abnormalities, macular holes or oedema, atrophy associated with degenerative diseases, glaucoma, and other retinal pathologies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBO	Tomography, Optical Coherence
HKI	Camera, Ophthalmic, Ac-Powered

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 70 and 106 KiloPascal
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d167f846-7e1e-4d99-ba2c-e1e858883177
Public Version Date: March 31, 2020
Public Version Number: 1
DI Record Publish Date: March 23, 2020