Probes for HOME

GUDID 06430033850626

Single unit blister package

ICARE FINLAND OY

Ophthalmic tonometer probe, sterile
Primary Device ID06430033850626
NIH Device Record Keybcb3cc40-6ea6-4040-a4a3-b5319feaf618
Commercial Distribution StatusIn Commercial Distribution
Brand NameProbes for HOME
Version Model NumberTP022
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430033850626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKXTonometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-12
Device Publish Date2017-03-24

On-Brand Devices [Probes for HOME]

06430033850626Single unit blister package
16430033850623Sales package 50pcs
06430033850947Sales package 20pcs of TP022 probes

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