AccessGUDID - DEVICE: Medmont Corneal Topographer E300 USB (09349221000033)

GUDID

Device Identifier (DI) Information

Brand Name: Medmont Corneal Topographer E300 USB
Version or Model: E300 USB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDMONT INTERNATIONAL PTY LTD

Primary DI Number: 09349221000033
Issuing Agency: GS1
Commercial Distribution End Date: October 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 746137249 *Terms of Use

Device Description: No description.

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):	No
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
HLQ	Keratoscope, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04c17965-76ef-4e64-802f-d2849650eeb7
Public Version Date: December 07, 2023
Public Version Number: 2
DI Record Publish Date: September 14, 2022