Identity
- Trade Name
- Ocu-Dot® Tonometer Probes - 100 Count FDA UDI
- Generic Name
- Ophthalmic tonometer probe FDA UDI
- Model / Reference
- 16318 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559012454 FDA UDI
- 510(k) Number
- K233516 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer probe 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer probe
Ocu-Dot® Tonometer Probes - 100 Count by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer probe.
- Probes for HOME — ICARE FINLAND OY · Class II
- Haag Streit UK — HAAG-STREIT UK LIMITED · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI 31e37133-8ea4-42de-89ab-b0cc0561b048 33 fields · synced Jun 8, 2026