Ocu-Film +

GUDID 00812559012089

Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

REICHERT, INC.

Ophthalmic tonometer tip cover

• Primary Device ID: 00812559012089
• NIH Device Record Key: 4f2b500d-5035-4a63-b46e-14cd97b56f2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocu-Film +
• Version Model Number: 230652
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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	00812559012089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070534

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

On-Brand Devices [Ocu-Film +]

• 00812559012096: Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr
• 00812559012089: Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr
• 00812559010115: Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr