Anodyne Surgical

FDA UDI

Class I (US FDA UDI)

by Psi/Eye-Ko, Inc.

Identity

Trade Name: Anodyne Surgical FDA UDI
Generic Name: Orbital depressor, reusable FDA UDI
Device Name: Schnocket Scleral Depressor dbl-end Hammer/Half-Ball tip, ang 16mm, 137mm, SS FDA UDI
Model / Reference: CX1001 FDA UDI
Description: Schnocket Scleral Depressor dbl-end Hammer/Half-Ball tip, ang 16mm, 137mm, SS FDA UDI

Identifiers

Primary DI / UDI-DI: 00840516142470 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Orbital depressor, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orbital depressor, 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 Orbital depressor, reusable.

Ambler Surgical — Ambler Surgical, LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
V. Mueller — STERIS CORPORATION · Class I
Bausch + Lomb — Bausch & Lomb Incorporated · Class I
Schepens Scleral Depressor — SONTEC INSTRUMENTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I

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 2052b466-a0a3-4717-b55a-1080533afce0 34 fields · synced Jun 8, 2026