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Automated Ophthalmics Softips

FDA UDI

Class II (US FDA UDI)

by Automated Ophthalmics, Inc.

Identity

Trade Name
Automated Ophthalmics Softips FDA UDI
Generic Name
Ophthalmic tonometer tip cover FDA UDI
Device Name
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. FDA UDI
Model / Reference
AO316 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860000603805 FDA UDI
510(k) Number
K992998 FDA UDI
FDA Product Code
HKY FDA UDI
GMDN Term
Ophthalmic tonometer tip cover FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.1930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Ophthalmic tonometer tip cover

Automated Ophthalmics Softips by Automated Ophthalmics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic tonometer tip cover.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Automated Ophthalmics, Inc.

Sources (1)

  • FDA UDI e00ec0bd-f4bc-4b22-b4f1-71efbd2a47a9 35 fields · synced May 30, 2026