AccessGUDID - DEVICE: Digital Refractor HDR-7000P (08800019600817)

GUDID

Device Identifier (DI) Information

Brand Name: Digital Refractor HDR-7000P
Version or Model: HDR-7000P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HDR-7000P
Company Name: Huvitz Co., Ltd.

Primary DI Number: 08800019600817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688154202 *Terms of Use

Device Description: Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.

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?
35299	Phoropter	An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKN	Refractor, Manual, Non-Powered, Including Phoropter

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
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Handling Environment Humidity: between -10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 978e62c4-90a7-43d8-a0b5-ad89461a3b3c
Public Version Date: June 20, 2023
Public Version Number: 1
DI Record Publish Date: June 12, 2023