AccessGUDID - DEVICE: Pentacam AXL (04049584012333)

GUDID

Device Identifier (DI) Information

Brand Name: Pentacam AXL
Version or Model: 70100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Primary DI Number: 04049584012333
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317138956 *Terms of Use

Device Description: While rotating around the eye, the Pentacam® AXL captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured and displayed by interferometry.

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?
18038	Corneal topography system	An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXK	Device,Analysis,Anterior Segment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152311	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 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
Weight: 7.9 Kilogram
Height: 430 Millimeter
Depth: 208 Millimeter
Width: 270 Millimeter

Device Record Status

Public Device Record Key: 374409a5-8836-4852-b570-f51c7a7e4866
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016