Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Schiotz tonometer weight - 15 gram FDA UDI
- Model / Reference
- 5761E FDA UDI
- Description
- Schiotz tonometer weight - 15 gram FDA UDI
Identifiers
- Catalog Number
- 5761E FDA UDI
- Primary DI / UDI-DI
- 00190660156053 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
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
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 5d2c83f7-ef74-47f1-b53f-0a700132aebf 36 fields · synced Jun 6, 2026