Tono-Pen® XL

GUDID 00812559010092

Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.

REICHERT, INC.

Ophthalmic tonometer, battery-operated
Primary Device ID00812559010092
NIH Device Record Key117bf0ad-bad6-4814-b669-b8288dc4bbec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTono-Pen® XL
Version Model Number230635
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
GS100812559010092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, Manual

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

Devices Manufactured by REICHERT, INC.

00812559010092 - Tono-Pen® XL2018-07-06Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.
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

Trademark Results [Tono-Pen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TONO-PEN
TONO-PEN
74433637 1844281 Live/Registered
REICHERT, INC.
1993-09-08

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