MedGyn MGC-200 Cryotherapy System 019000

GUDID M803019000

unit, cryosurgical, accessories

MEDGYN PRODUCTS, INC.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: M803019000
• NIH Device Record Key: a5fea321-0e31-486b-867a-e0676d311ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedGyn MGC-200 Cryotherapy System
• Version Model Number: unit, cryosurgical, accessories
• Catalog Number: 019000
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M803019000 [Primary]

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-08
• Device Publish Date: 2024-04-30

Devices Manufactured by MEDGYN PRODUCTS, INC.

• M803038030 - Lletz Graves Speculum Small, Closed Tube: 2025-04-28 Lletz Graves Speculum Small, Closed Tube 3/4 inch x 3inch (19mm x 76mm)
• M803038031 - Lletz Graves Speculum Medium, Closed Tube: 2025-04-28 Lletz Graves Speculum Medium, Closed Tube 1 3/8" x 4" (35mm x 102mm)
• M803038032 - Lletz Graves Speculum Large, Closed Tube: 2025-04-28 Lletz Graves Speculum Large, Closed Tube 1 3/8" x 4 3/4" (35mm x 121mm)
• M803038033 - Lletz Graves Speculum Extra Large, Closed Tube: 2025-04-28 Lletz Graves Speculum Extra Large, Closed Tube 1 1/2" x 61/2" (38mm x 165mm)
• M803038040 - Lletz Pederson Speculum Small, Closed Tube: 2025-04-28 Lletz Pederson Speculum Small, Closed Tube 1/2" x 3" (13mm x 76mm)
• M803038041 - Lletz Pederson Speculum Medium, Closed Tube: 2025-04-28 Lletz Pederson Speculum Medium, Closed Tube 7/8" x 4" (22mm x 102mm)
• M803038042 - Lletz Pederson Speculum Large, Closed Tube: 2025-04-28 Lletz Pederson Speculum Large, Closed Tube 1" x 4 3/4" (25mm x 121mm)
• M803038043 - Lletz Pederson Speculum Extra Large, Closed Tube: 2025-04-28 Lletz Pederson Speculum Extra Large, Closed Tube 1" x 6 1/2" (25mm x 165mm)