AccessGUDID - DEVICE: Focimeter (06971922130103)

GUDID

Device Identifier (DI) Information

Brand Name: Focimeter
Version or Model: CCQ-500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Chongqing Yeasn Science & Technology Co.,Ltd.

Primary DI Number: 06971922130103
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 547954649 *Terms of Use

Device Description: mainly measures spherical power, cylindrical power and axis of the cylindrical lens as well as contact lens. It marks on the uncut lens and checks if the spectacle lens is correctly mounted.

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?
12326	Manually-adjusted lensmeter, line-powered	A mains electricity (AC-powered) ophthalmic instrument designed to measure the focusing power (dioptric power) and other optical characteristics of a spectacle lens, contact lens, or prism through manual adjustments to the instrument performed by the operator. Alternating current provides power for illumination [e.g., with a light-emitting diode (LED)] to make the measurements which are read directly through the optics.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLM	Instrument, Measuring, Lens, 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: 4844ecac-9aba-4a9e-ba3f-cd7d76c13fc6
Public Version Date: August 22, 2024
Public Version Number: 2
DI Record Publish Date: March 03, 2021