Cusco Medium w/Center Screw

FDA UDI

Class I (US FDA UDI)

by Medgyn Products, Inc.

Identity

Trade Name: Cusco Medium w/Center Screw FDA UDI
Generic Name: Vaginal speculum, reusable FDA UDI
Device Name: Cusco Medium w/Center Screw 1 3/8" x 4" (35mm x 102mm) FDA UDI
Model / Reference: Cusco Medium w/Center Screw 1 3/8" x 4" (35mm x 102mm) FDA UDI
Description: Cusco Medium w/Center Screw 1 3/8" x 4" (35mm x 102mm) FDA UDI

Identifiers

Catalog Number: 030961 FDA UDI
Primary DI / UDI-DI: M803030961 FDA UDI
FDA Product Code: HDF FDA UDI
GMDN Term: Vaginal speculum, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4520 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

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Vaginal speculum, reusable

Cusco Medium w/Center Screw by Medgyn Products, 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: Medgyn Products, Inc.

Sources (1)

FDA UDI 93565a60-f1e8-45d9-b24b-724743ca769f 34 fields · synced Jun 1, 2026