Cusco Large w/Side Screw

Basic Information

• Brand Name: Cusco Large w/Side Screw
• Primary DI: M803030965
• Version / Model: Cusco Large w/Side Screw 1 3/8" x 4 1/2" (35mm x 114mm)
• Catalog Number: 030965
• Company Name: MEDGYN PRODUCTS, INC.
• Labeler DUNS: 103913430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-26
• Public Version: 1
• Public Version Date: 2025-06-03
• Public Version Status: New
• Public Device Record Key: 7bc58908-224e-4481-9b47-33be826c8022

Device Description

Cusco Large w/Side Screw 1 3/8" x 4 1/2" (35mm x 114mm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35352	Vaginal speculum, reusable	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M803030965	HIBCC