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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Fibreoptic retractor handle FDA UDI
Device Name
Fiber Optic Retractor, 12mm X 40mm Blade, Black Plastic Handle FDA UDI
Model / Reference
SD123402414-60 FDA UDI
Description
Fiber Optic Retractor, 12mm X 40mm Blade, Black Plastic Handle FDA UDI

Identifiers

Catalog Number
SD123402414-60 FDA UDI
Primary DI / UDI-DI
B382SD123402414600 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Fibreoptic retractor handle 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

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fibreoptic retractor handle

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

Similar devices

Also classified as Fibreoptic retractor handle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI 002e87c1-4dd9-4933-a481-c2c032c0a894 35 fields · synced Jun 1, 2026