AccessGUDID - DEVICE: Icare ic200 (06430033851036)

GUDID

Device Identifier (DI) Information

Brand Name: Icare ic200
Version or Model: TA031
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ICARE FINLAND OY

Primary DI Number: 06430033851036
Issuing Agency: GS1
Commercial Distribution End Date: June 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 651755092 *Terms of Use

Device Description: The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.

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":	Yes
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 385b0c2f-6aef-4469-9264-e6d57d5075ac
Public Version Date: April 23, 2024
Public Version Number: 2
DI Record Publish Date: January 17, 2020