AccessGUDID - DEVICE: Applanation Tonometer (00869228000441)

GUDID

Device Identifier (DI) Information

Brand Name: Applanation Tonometer
Version or Model: AT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Trevi Technology, Inc.

Primary DI Number: 00869228000441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078605507 *Terms of Use

Device Description: IBEX Tonometer is used for determining intraocular tension by measuring the pressure required to flatten a small area of the cornea.

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?
32721	Ophthalmic tonometer, manual	An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with 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 device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023676	000

Device Exempt from Premarket Submission: No 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: 4951d709-bb91-49aa-aa54-6597132972f6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 01, 2018