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.

• M8030030976 - Graves Vu-Max Large: 2025-06-03 Graves Vu-Max Large 5" (127mm)
• M803030906 - Pederson Small: 2025-06-03 Pederson Small 1/2" x 3" (13mm x 76mm)
• M803030907 - Pederson Medium: 2025-06-03 Pederson Medium 7/8" x 4" (22mm x 102mm)
• M803030908 - Pederson Large: 2025-06-03 Pederson Large 1" x 4 3/4" (25mm x 121mm)
• M803030910 - Graves Wide Angled Medium Right Side Open: 2025-06-03 Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm)
• M803030911 - Weisman Graves Medium - Right Side Open: 2025-06-03 Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm)
• M803030912 - Weisman Graves Medium: 2025-06-03 Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm)
• M803030913 - Pederson XSmall: 2025-06-03 Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm)