VISUPLAN 500

GUDID 00812559012195

AC-powered, non-contact tonometer indicated for measuring intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement.

REICHERT, INC.

Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered Ophthalmic tonometer, line-powered
Primary Device ID00812559012195
NIH Device Record Key5f957036-35ea-4da3-9a6c-c26fa455e555
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISUPLAN 500
Version Model Number16080
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
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812559012195 [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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

Devices Manufactured by REICHERT, INC.

00812559010092 - Tono-Pen® XL2018-07-06 Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected g
00812559010108 - Tono-Pen AVIA®2018-07-06 Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected gla
00812559010115 - Ocu-Film +2018-07-06 Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps pr
00812559010221 - CT210 Contact Tonometer2018-07-06 Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye.
00812559010429 - PT100 Portable Non-Contact Tonometer2018-07-06 Handheld, battery-powered, non-contact tonometer intended to measure the intraocular pressure of the eye. An air puff is used t
00812559010498 - PSL Portable Slit Lamp2018-07-06 Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It is intended for use in eye examinatio
00812559010504 - Xcel® 255 Slit Lamp 2018-07-06 AC powered biomicroscope that projects light into a patient's eye. The device is intended for use in examining the anterior se
00812559010955 - Model 30 Pneumatonometer2018-07-06 AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a s
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.