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Diamatrix

FDA UDI

Class I (US FDA UDI)

by Diamatrix

Identity

Trade Name
Diamatrix FDA UDI
Generic Name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
Device Name
Irrigating/Aspirating 90° tip only, 16 Gauge Outer Sleeve, 21 Gauge Closed Inner Cannula tip with .3mm Aspirating Port, 17mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 37mm total length, Stainless FDA UDI
Model / Reference
IS-.3-90 FDA UDI
Description
Irrigating/Aspirating 90° tip only, 16 Gauge Outer Sleeve, 21 Gauge Closed Inner Cannula tip with .3mm Aspirating Port, 17mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 37mm total length, Stainless FDA UDI

Identifiers

Primary DI / UDI-DI
00813059014863 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Diamatrix by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diamatrix

Sources (1)

  • FDA UDI 603bf234-a5df-4706-95ef-95148cb48fd6 33 fields · synced May 30, 2026