AccessGUDID - DEVICE: AUTO LENSMETER (06971821408020)

GUDID

Device Identifier (DI) Information

Brand Name: AUTO LENSMETER
Version or Model: TL-6800
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ningbo Ming Sing Optical R & D Co., Ltd.

Primary DI Number: 06971821408020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654386890 *Terms of Use

Device Description: TL-6800 Auto lensmeter Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results Green spectral measurement light source Higher level hardware, good tracing performance of the optical system and faster measurement speed Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens UV measurement Humanized design, tiltable screen, comfortable operation and easier for observation Data can be transferred to auto phoropter

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?
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: 16348550-73ae-480e-9cf9-46f2be3bdd2c
Public Version Date: December 10, 2019
Public Version Number: 1
DI Record Publish Date: December 02, 2019