Identity
- Trade Name
- Schioetz Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Manual Tonometer is used to gauge the internal pressure of the eye using weights and a tonometer tip. FDA UDI
- Model / Reference
- 13107 FDA UDI
- Description
- Manual Tonometer is used to gauge the internal pressure of the eye using weights and a tonometer tip. FDA UDI
Identifiers
- Catalog Number
- 13107 FDA UDI
- Primary DI / UDI-DI
- B091131070 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Inch FDA UDILength — 5.25 Inch FDA UDI
Schioetz Tonometer by Gulden Ophthalmics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Gulden Ophthalmics
Sources (1)
- FDA UDI 658bba3d-2491-4925-a5a9-8dbfaff1b885 37 fields · synced Jun 8, 2026