Identity
- Trade Name
- CT100 Contact Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Non-active contact, applanation tonometer intended to measure intraocular pressure of the eye. FDA UDI
- Model / Reference
- 12591 FDA UDI
- Description
- Non-active contact, applanation tonometer intended to measure intraocular pressure of the eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056098470463 FDA UDI
- 510(k) Number
- K022054 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 FDA UDI
- Commercial Distribution
- Not 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
CT100 Contact Tonometer by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K022054 also covers:
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 061cde0f-d07a-4d88-8dd7-e772675e674f 36 fields · synced Jun 8, 2026