AccessGUDID - DEVICE: Icare tonometer probes (06430033850565)

GUDID

Device Identifier (DI) Information

Brand Name: Icare tonometer probes
Version or Model: TP01s
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ICARE FINLAND OY

Primary DI Number: 06430033850565
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 651755092 *Terms of Use

Device Description: No description.

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:	Yes
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?
62405	Ophthalmic tonometer probe	A device intended to be attached to an ophthalmic tonometer and to make brief and gentle contact with the eye surface for the measurement of intraocular pressure (IOP). It may be in the form of a prism with a dedicated mount (mount may be included with the device) or a thin metal or plastic rod with a plastic distal tip designed to be moved towards the eye by the tonometer (e.g., via magnetization), which uses probe deceleration and rebound time measurements to calculate IOP. This is a single-use device.	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
K153694	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: abcb24ee-8c10-42b8-893e-17f38d8df3b9
Public Version Date: February 20, 2023
Public Version Number: 4
DI Record Publish Date: December 01, 2016