Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name: Surgical Direct FDA UDI
Generic Name: Vaginal speculum, reusable FDA UDI
Device Name: 25mm x 180mm Breisky Vaginal Retractor FDA UDI
Model / Reference: SD91509590 FDA UDI
Description: 25mm x 180mm Breisky Vaginal Retractor FDA UDI

Identifiers

Catalog Number: SD91509590 FDA UDI
Primary DI / UDI-DI: B382SD915095900 FDA UDI
FDA Product Code: GAF FDA UDI
GMDN Term: Vaginal speculum, reusable 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

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: Vaginal speculum, reusable

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

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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 83896644-a0c7-4664-8ddf-a0b86576eca3 35 fields · synced May 31, 2026