AccessGUDID - DEVICE: Corvis STL (04049584014085)

GUDID

Device Identifier (DI) Information

Brand Name: Corvis STL
Version or Model: 72300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Primary DI Number: 04049584014085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317138956 *Terms of Use

Device Description: The Corvis® ST is a non-contact tonometer equipped with an optical Pachymetry function. The Corvis® ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. During the air puff the eye gets illuminated by a 9 mm slit through the apex and a built-in high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera uses a sequence of 140 Scheimpflug images of the cornea which are analyzed by a built-in computer. Intra ocular pressure is determined by the detection of the applanation moments of the cornea.

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?
16809	Ophthalmic tonometer, battery-operated	An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKX	Tonometer, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113066	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
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 14 Kilogram
Height: 520 Millimeter
Depth: 520 Millimeter
Width: 270 Millimeter

Device Record Status

Public Device Record Key: 42c8b831-8fcf-482b-a101-ecb6aa97f1db
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016