Icare HOME tonometer

GUDID 06430033851074

ICARE FINLAND OY

Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated Ophthalmic tonometer, battery-operated
Primary Device ID06430033851074
NIH Device Record Key200a9e90-d56c-4397-946e-c9e761c45765
Commercial Distribution StatusIn Commercial Distribution
Brand NameIcare HOME tonometer
Version Model NumberTA022
Company DUNS651755092
Company NameICARE FINLAND OY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430033851074 [Primary]
GS106430033851074 [Primary]
GS106430033851074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, Manual
HKYTonometer, Manual
HKYTonometer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Icare HOME tonometer]

06430033850237TA022
06430033851074TA022

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.