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 ID: 00812559010092
• NIH Device Record Key: 117bf0ad-bad6-4814-b669-b8288dc4bbec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tono-Pen® XL
• Version Model Number: 230635
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812559010092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852774

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by REICHERT, INC.

• 00812559010092 - Tono-Pen® XL: 2018-07-06Handheld, 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® XL: 2018-07-06 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 Tonometer: 2018-07-06 Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye.
• 00812559010429 - PT100 Portable Non-Contact Tonometer: 2018-07-06 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 Lamp: 2018-07-06 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 Pneumatonometer: 2018-07-06 AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a s