Ocu-Dot® Tonometer Probes - 100 Count

GUDID 00812559012324

REICHERT, INC.

Ophthalmic tonometer probe

• Primary Device ID: 00812559012324
• NIH Device Record Key: 31e37133-8ea4-42de-89ab-b0cc0561b048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocu-Dot® Tonometer Probes - 100 Count
• Version Model Number: 16318
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• Device Count: 100
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812559012324 [Unit of Use]
GS1	00812559012454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233516

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-20
• Device Publish Date: 2025-08-12

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