Identity
- Trade Name
- Medetz Surgical Instruments FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
- Device Name
- I/A Silicone 45 Degree Tip ONLY, Silicone Outer Sleeve, 21ga Closed Inner Cannula tip with .3mm Aspirating Port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Titanium with Stainless Inner Tube FDA UDI
- Model / Reference
- iat-.3s-45 FDA UDI
- Description
- I/A Silicone 45 Degree Tip ONLY, Silicone Outer Sleeve, 21ga Closed Inner Cannula tip with .3mm Aspirating Port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length, Titanium with Stainless Inner Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- G223IAT3S45 FDA UDI
- FDA Product Code
- KYG FDA UDI
- GMDN Term
- Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4360 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
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic surgical irrigation/infusion/aspiration handle, reusable
Medetz Surgical Instruments by Medetz Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, reusable.
- Stephens Instruments — KRISHNA IMPORTS INC · Class I
- Irrigation and Aspiration — AURORA SURGICAL, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Volk Infusion Handle — VOLK OPTICAL INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Bi-Manual Irrigation/Aspiration — AURORA SURGICAL, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medetz Surgical Instruments
Sources (1)
- FDA UDI 0dab92b6-f16e-4651-84bc-54a27c93ba78 34 fields · synced Jun 1, 2026