iPac® Pachymeter

GUDID 00812559011228

Handheld, battery-powered, ultrasound device intended to measure the thickness of the cornea. The device tip is touched to a patient's eye during the measurement.

REICHERT, INC.

Ultrasound pachymeter

• Primary Device ID: 00812559011228
• NIH Device Record Key: cebfa8cd-5cf3-41bf-b636-19aa8a535c41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iPac® Pachymeter
• Version Model Number: 16040
• 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	00812559011228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030610

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by REICHERT, INC.

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• 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