AccessGUDID - DEVICE: Icare TA01i (06430033850060)

GUDID

Device Identifier (DI) Information

Brand Name: Icare TA01i
Version or Model: TA01i
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ICARE FINLAND OY

Primary DI Number: 06430033850060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 651755092 *Terms of Use

Device Description: The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare tonometer TA01i is intended to be used for the measurement of 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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063873	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: fe3cd346-ba06-41ad-8e91-64faf1a8c6ed
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016