Identity
- Trade Name
- Diamatrix Ltd. FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Irrigating/Aspirating 45° tip only, 16 Gauge Outer Sleeve, 21 Gauge Closed Inner Cannula tip with .5mm Aspirating Port, 19mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 37mm total length, Titanium with Stainless Inner Tubing FDA UDI
- Model / Reference
- IT-.5-45 FDA UDI
- Description
- Irrigating/Aspirating 45° tip only, 16 Gauge Outer Sleeve, 21 Gauge Closed Inner Cannula tip with .5mm Aspirating Port, 19mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 37mm total length, Titanium with Stainless Inner Tubing FDA UDI
Identifiers
- Catalog Number
- IT-.5-45 FDA UDI
- Primary DI / UDI-DI
- 00813059019516 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Diamatrix Ltd. by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.
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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
- Diamatrix
Sources (1)
- FDA UDI b29750f6-8be4-4e4e-9762-a55542088ed8 35 fields · synced May 29, 2026