Anodyne Surgical

FDA UDI

Class I (US FDA UDI)

by Psi/Eye-Ko, Inc.

Identity

Trade Name: Anodyne Surgical FDA UDI
Generic Name: Ophthalmic needle, single-use FDA UDI
Device Name: Retrobulbar Needle [Non Atkinson] 25g X 38mm (1 1/2") FDA UDI
Model / Reference: 0008 FDA UDI
Description: Retrobulbar Needle [Non Atkinson] 25g X 38mm (1 1/2") FDA UDI

Identifiers

Primary DI / UDI-DI: 00840516110875 FDA UDI
FDA Product Code: GAA FDA UDI
GMDN Term: Ophthalmic needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Ophthalmic needle, 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 needle, single-use.

Anaesthetic Needles — STERIMEDIX LIMITED · Class II
Needle aspiration and injection — Katena Products, Inc. · Class I
OMNI Edge Surgical System — Sight Sciences, Inc. · Class II
STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) — TSK LABORATORY INTERNATIONAL JAPAN K.K. · Class II
Disposable Instruments — OASIS Medical, Inc. · Class I
Anaesthetic Needles — STERIMEDIX LIMITED · Class II
Needle aspiration and injection — Katena Products, Inc. · Class I
Anaesthetic Needles — STERIMEDIX LIMITED · Class II

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: Psi/Eye-Ko, Inc.

Sources (1)

FDA UDI cf7211c0-67c0-4477-a90f-41c71f5a46ea 34 fields · synced May 30, 2026