AccessGUDID - DEVICE: Lensmeter (06973211070688)

GUDID

Device Identifier (DI) Information

Brand Name: Lensmeter
Version or Model: SK-1000A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD

Primary DI Number: 06973211070688
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545824560 *Terms of Use

Device Description: It is mainly used to measure the vertex power and prism power of various spectacle lenses, determine the position and direction of the column lens axis, print marks on the unprocessed lens, and check whether the lens are correctly installed in the frame

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?
45753	Automated lensmeter	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. The device is fully automated and does not require manual adjustments of its measurement systems. It provides the operator with automatic readings on an integral screen, and will typically record and print-out the results.	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: 52745e92-13b1-40a7-be21-a8778ba8c9b7
Public Version Date: July 10, 2020
Public Version Number: 1
DI Record Publish Date: July 02, 2020