Surgical Direct

FDA UDI

Class II (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Head-worn fibreoptic light FDA UDI
Device Name: Visualus, Fiber Optic, Surgical Headlight, 90Â° Headlight, Detachable Joysticks, Bifurcated Cable, 9f FDA UDI
Model / Reference: SD3200 FDA UDI
Description: Visualus, Fiber Optic, Surgical Headlight, 90Â° Headlight, Detachable Joysticks, Bifurcated Cable, 9f FDA UDI

Identifiers

Catalog Number: SD3200 FDA UDI
Primary DI / UDI-DI: B382SD32000 FDA UDI
510(k) Number: K061690 FDA UDI
FDA Product Code: FST FDA UDI
GMDN Term: Head-worn fibreoptic light FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 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

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: Head-worn fibreoptic light

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

Similar devices

Also classified as Head-worn fibreoptic light.

Sunoptic Technologies — Sunoptic Technologies · Class II
90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
105 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
Surgical Headlight — GULF FIBEROPTICS, INC. · Class II

Cleared under the same submission

K061690 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Surgical Direct, Inc.

Sources (1)

FDA UDI 05f14942-61de-4378-bca6-b4db0f1a3bc4 36 fields · synced May 31, 2026