AccessGUDID - DEVICE: Non-contact Tonometer HNT-1 (08800019600428)

GUDID

Device Identifier (DI) Information

Brand Name: Non-contact Tonometer HNT-1
Version or Model: HNT-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HNT-1
Company Name: Huvitz Co., Ltd.

Primary DI Number: 08800019600428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688154202 *Terms of Use

Device Description: The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human 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?
16809	Ophthalmic tonometer, battery-operated	An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKX	Tonometer, 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: 09a5b070-9998-4f64-b7bf-60e4809ec058
Public Version Date: December 12, 2019
Public Version Number: 2
DI Record Publish Date: May 10, 2019