AccessGUDID - DEVICE: Opthalmic Table HRT-7000 (08800019600244)

GUDID

Device Identifier (DI) Information

Brand Name: Opthalmic Table HRT-7000
Version or Model: HRT-7000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HRT-7000
Company Name: Huvitz Co., Ltd.

Primary DI Number: 08800019600244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688154202 *Terms of Use

Device Description: Opthalmic Table is produced for being used by loading the necessary equipment for the medical care act.

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?
36400	Ophthalmic instrument table, line-powered	A mains electricity (AC-powered) device designed as a work surface, with or without storage compartments, that supports ophthalmic instruments (e.g., slit lamp, keratometer, refractometer, and hand instruments) for the examination/treatment of a patient's eyes. It has powered height adjustments enabling the clinician to raise/lower the surface, or seated patient, to align the instruments to the patient's eye level. Some designs may incorporate the patient chair as part of the unit and even facilitate easy swinging aside mechanisms to accommodate wheelchair bound patients. Controls may enable the adjustment of peripheral devices within the examination room.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRJ	Table, Instrument, Powered, 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: 3bc12553-aa87-4254-ae5e-e4b850cf33db
Public Version Date: May 20, 2019
Public Version Number: 1
DI Record Publish Date: May 10, 2019