Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Schiotz tonometer with inclined scale, manufactured and certified by Gulden Ophthalmic, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights FDA UDI
- Model / Reference
- 5754E FDA UDI
- Description
- Schiotz tonometer with inclined scale, manufactured and certified by Gulden Ophthalmic, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights FDA UDI
Identifiers
- Catalog Number
- 5754E FDA UDI
- Primary DI / UDI-DI
- 00190660156084 FDA UDI
- 510(k) Number
- K945541 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
- 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic tonometer, manual
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, manual.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- KAT APPLANATION PRISM — KEELER LIMITED · Class II
- LuxVision — U.S. OPHTHALMIC, L.L.C. · Class II
- Sklar® — Sklar Corporation · Class II
- Keeler Disposable Tonomate - BX 100 — KEELER LIMITED · Class II
- SCHIOTZ TONOMETER — Katena Products, Inc. · Class II
- Applanation Tonometer — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
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
- 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 — 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 67ca8da9-7d82-4423-b25c-c4de167afe4b 36 fields · synced Jun 1, 2026