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Anodyne Surgical

FDA UDI

Class I (US FDA UDI)

by Psi/Eye-Ko, Inc.

Identity

Trade Name
Anodyne Surgical FDA UDI
Generic Name
Ophthalmic surgical irrigation/infusion/aspiration handle, reusable FDA UDI
Device Name
I/A Str Tip, 16ga Outer Sleeve, 21ga Inner Cannula tip with .3mm Asp Port, SS FDA UDI
Model / Reference
CC2001 FDA UDI
Description
I/A Str Tip, 16ga Outer Sleeve, 21ga Inner Cannula tip with .3mm Asp Port, SS FDA UDI

Identifiers

Primary DI / UDI-DI
00840516131061 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Ophthalmic surgical irrigation/infusion/aspiration handle, 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic surgical irrigation/infusion/aspiration handle, reusable

Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Psi/Eye-Ko, Inc.

Sources (1)

  • FDA UDI 7085cb51-b02a-475e-8824-593f198cd87f 34 fields · synced Jun 8, 2026