Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Allen-Schiotz tonometer with Plunger Retractor and inclined scale, manufactured and certified by Gulden Ophthalmics, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights FDA UDI
- Model / Reference
- 5757E FDA UDI
- Description
- Allen-Schiotz tonometer with Plunger Retractor and inclined scale, manufactured and certified by Gulden Ophthalmics, supplied with case, tables, zero test block and 5.5, 7.5, 10 and 15 gram weights FDA UDI
Identifiers
- Catalog Number
- 5757E FDA UDI
- Primary DI / UDI-DI
- 00190660156022 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
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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
- 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 |
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Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 11ee7547-19aa-4c48-9758-2b38f839d363 36 fields · synced Jun 8, 2026