Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Corneal marker, single-use FDA UDI
Device Name: 5 1/4 Inch O Conner Scleral Depressor-Marker, 3mm Tear Drop Shape End, and 1.5mm Gass Marker End FDA UDI
Model / Reference: S34291.100 FDA UDI
Description: 5 1/4 Inch O Conner Scleral Depressor-Marker, 3mm Tear Drop Shape End, and 1.5mm Gass Marker End FDA UDI

Identifiers

Catalog Number: S34291.100 FDA UDI
Primary DI / UDI-DI: B382S342911000 FDA UDI
FDA Product Code: HMR FDA UDI
GMDN Term: Corneal marker, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4570 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Corneal marker, single-use

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corneal marker, single-use.

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Scleral Markers — STERIMEDIX LIMITED · Class II
Anmuth Medical International — ANMUTH MEDICAL INTERNATIONAL LLC · Class I
Anmuth Medical International — ANMUTH MEDICAL INTERNATIONAL LLC · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · 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: Surgical Direct, Inc.

Sources (1)

FDA UDI 5fbc4d00-d558-4352-9aad-98d75ff5b8de 35 fields · synced May 31, 2026