Automated Ophthalmics Softips

GUDID 00860000603805

A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.

AUTOMATED OPHTHALMICS, INC.

Ophthalmic tonometer tip cover

• Primary Device ID: 00860000603805
• NIH Device Record Key: e00ec0bd-f4bc-4b22-b4f1-71efbd2a47a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Ophthalmics Softips
• Version Model Number: AO316
• Company DUNS: 929977858
• Company Name: AUTOMATED OPHTHALMICS, 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000603805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992998

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

[00860000603805]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-25
• Device Publish Date: 2022-11-17