AccessGUDID - DEVICE: Auto Ref-Keratometer HRK-8000A (08800019600152)

GUDID

Device Identifier (DI) Information

Brand Name: Auto Ref-Keratometer HRK-8000A
Version or Model: HRK-8000A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HRK-8000A
Company Name: Huvitz Co., Ltd.

Primary DI Number: 08800019600152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688154202 *Terms of Use

Device Description: The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye

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?
36387	Ophthalmic refractometer, manual	A manually-operated ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina); typically the measurements are made in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information the optometrist can calculate the lens prescription needed to correct the patient's refractive error. With advanced instruments the measurements are made automatically with printed verification.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HKO	Refractometer, Ophthalmic

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: 8a2a7d67-da43-421b-b373-605912efd7bf
Public Version Date: May 20, 2019
Public Version Number: 1
DI Record Publish Date: May 10, 2019