AccessGUDID - DEVICE: Auto Lensmeter HLM-1 (08800019600442)

GUDID

Device Identifier (DI) Information

Brand Name: Auto Lensmeter HLM-1
Version or Model: HLM-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HLM-1
Company Name: Huvitz Co., Ltd.

Primary DI Number: 08800019600442
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688154202 *Terms of Use

Device Description: Lensmeter is a machine to generate Sph, Cyl and Axis information of lens by measuring refraction of the lens

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: 16095fb5-7293-467f-bdfc-a87bbc676feb
Public Version Date: May 20, 2019
Public Version Number: 1
DI Record Publish Date: May 10, 2019