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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
11 inch St. Marks Lighted Deep Pelvic Retractor, Tapered Tip 2 3/16 inch x 1 3/4 inch With Lip FDA UDI
Model / Reference
SD40-0008 FDA UDI
Description
11 inch St. Marks Lighted Deep Pelvic Retractor, Tapered Tip 2 3/16 inch x 1 3/4 inch With Lip FDA UDI

Identifiers

Catalog Number
SD40-0008 FDA UDI
Primary DI / UDI-DI
B382SD4000080 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 ccb76b0e-ff4a-425d-a760-2792240d6806 35 fields · synced Jun 1, 2026