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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, single-use FDA UDI
Device Name
Male/Female Handpiece FDA UDI
Model / Reference
8601 FDA UDI
Description
Male/Female Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
00840516130477 FDA UDI
FDA Product Code
KYG FDA UDI
GMDN Term
Ophthalmic surgical irrigation/infusion/aspiration handle, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic surgical irrigation/infusion/aspiration handle, single-use

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, single-use.

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 c673ecf7-f9ac-4818-93bb-1276381a7f9b 34 fields · synced Jun 8, 2026