Identity
- Trade Name
- Ocular Response Analyzer® G3 FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- AC-powered, non-contact tonometer intended to measure the intraocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement. FDA UDI
- Model / Reference
- 16170 FDA UDI
- Description
- AC-powered, non-contact tonometer intended to measure the intraocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559011976 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, line-powered 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, line-powered
Ocular Response Analyzer® G3 by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, line-powered.
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- Falck Medical Multi-Function Applanation Tonometer — Falck Medical, Inc. · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI 5512351b-3aa9-459b-a2bb-4c5a0139774a 34 fields · synced Jun 1, 2026