PT100 Portable Non-Contact Tonometer

GUDID 00812559010429

Handheld, battery-powered, non-contact tonometer intended to measure the intraocular pressure of the eye. An air puff is used to momentarily flatten a patient's cornea during the measurement.

REICHERT, INC.

Ophthalmic tonometer, battery-operated
Primary Device ID00812559010429
NIH Device Record Keyecd4ea28-9945-42cd-b2dd-c98162ac13f9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePT100 Portable Non-Contact Tonometer
Version Model Number13850
Company DUNS126650253
Company NameREICHERT, INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812559010429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKXTonometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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