Identity
- Trade Name
- Integra® Miltex® FDA UDI
- Generic Name
- Ophthalmic tonometer, manual FDA UDI
- Device Name
- Integra® Miltex® Schiotz Tonometer Original model with 5.5 g, and 10 g weigths FDA UDI
- Model / Reference
- 18132 FDA UDI
- Description
- Integra® Miltex® Schiotz Tonometer Original model with 5.5 g, and 10 g weigths FDA UDI
Identifiers
- Catalog Number
- 18-132 FDA UDI
- Primary DI / UDI-DI
- 10381780159544 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
Integra® Miltex® by Integra LifeSciences Production Corporation — 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
- Ambler Surgical — Ambler Surgical, LLC · 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
- Ambler Surgical — Ambler Surgical, LLC · 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
- Ambler Surgical — Ambler Surgical, LLC
- 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 2cea0b02-c476-40b0-9ee7-bdc8ede998d6 36 fields · synced Jun 9, 2026