DEVICE: Optos OCT/SLO (05057056003856)

Download: XML | JSON

Device Identifier (DI) Information

Optos OCT/SLO
OCT
000385
OPTOS PUBLIC LIMITED COMPANY
05057056003856
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Scanning-laser ophthalmic imaging system An assembly of mains electricity (AC-powered) ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OBO Tomography, Optical Coherence
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 50 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
November 23, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+0441383843351
gmcleod@optos.com
CLOSE