AccessGUDID - DEVICE: OCT Ophthalmoscope (05057056107509)

GUDID

Device Identifier (DI) Information

Brand Name: OCT Ophthalmoscope
Version or Model: P200TxE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A10750
Company Name: OPTOS PUBLIC LIMITED COMPANY

Primary DI Number: 05057056107509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346013337 *Terms of Use

Device Description: A desktop retinal imaging device that can perform ultra-widefield scanning laser ophthalmoscopy and targeted navigated optical coherence tomography.

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?
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 [?]
K190732	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
Handling Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 570 Millimeter
Width: 540 Millimeter
Height: 683 Millimeter

Device Record Status

Public Device Record Key: e22328b6-592c-42a3-98c4-5c5b8c40ed35
Public Version Date: November 06, 2019
Public Version Number: 1
DI Record Publish Date: October 29, 2019