Identity
- Trade Name
- schiötz C tonometer, inclined scale, silver FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- The eye tonometer used to measuring the intra-ocular pressure. FDA UDI
- Model / Reference
- 5112 FDA UDI
- Description
- The eye tonometer used to measuring the intra-ocular pressure. FDA UDI
Identifiers
- Catalog Number
- 5112 FDA UDI
- Primary DI / UDI-DI
- 04045396007109 FDA UDI
- 510(k) Number
- K945541 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, battery-operated 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer, battery-operated
schiötz C tonometer, inclined scale, silver by Rudolf Riester GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945541 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Integra® Miltex® — Integra LifeSciences Production Corporation
- schiötz A tonometer, straight scale, silver — Rudolf Riester GmbH & Co. KG
- schiötz B tonometer, inclined scale, silver — Rudolf Riester GmbH & Co. KG
- schiötz C tonometer, inclined scale, gold — Rudolf Riester GmbH & Co. KG
- schiötz C tonometer, inclined scale, silver, with 4 weights — Rudolf Riester GmbH & Co. KG
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
- Rudolf Riester GmbH & Co. KG
Sources (1)
- FDA UDI f390ad4b-8e47-4c40-b4f0-34f583a392c3 35 fields · synced May 31, 2026