Identity
- Trade Name
- EASY CHANGE IRRIGATION ASPIRATION SYSTEM HANDLE FDA UDI
- Generic Name
- Ophthalmic cannulation set, reusable FDA UDI
- Device Name
- EASY CHANGE IRRIGATION ASPIRATION SYSTEM HANDLE TITANIUM FDA UDI
- Model / Reference
- T16-3100 FDA UDI
- Description
- EASY CHANGE IRRIGATION ASPIRATION SYSTEM HANDLE TITANIUM FDA UDI
Identifiers
- Catalog Number
- T16-3100 FDA UDI
- Primary DI / UDI-DI
- 00192896094932 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic cannulation set, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic cannulation set, reusable
Easy Change Irrigation Aspiration System Handle by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic cannulation set, reusable.
- Reusable universal cannula.(20 gauge / 0.9 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- Medetz Surgical Instruments — MEDETZ SURGICAL INSTRUMENTS · Class I
- Reusable Two step cannula system.(23 gauge / 0.6 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
- EASY CHANGE IRRIGATION ASPIRATION SYSTEM TIP — SONTEC INSTRUMENTS, INC. · Class I
- EASY CHANGE IRRIGATION ASPIRATION SYSTEM TIP — SONTEC INSTRUMENTS, INC. · Class I
- ANGLED TIP — SONTEC INSTRUMENTS, INC. · Class I
- ANGLED TIP — SONTEC INSTRUMENTS, INC. · Class I
- STRAIGHT TIP — SONTEC INSTRUMENTS, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI f7726df8-7005-45a6-9077-e9518156beb8 35 fields · synced Jun 6, 2026