MedGyn Flexible/Karman Cannula-Curette 11mm 022012K

GUDID M803K022012

12mm Flexible/Karman Curette

MEDGYN PRODUCTS, INC.

Intrauterine cannula, single-use

• Primary Device ID: M803K022012
• NIH Device Record Key: c9bd226a-3cf5-48a2-bf69-983d20edfc73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedGyn Flexible/Karman Cannula-Curette 11mm
• Version Model Number: 12mm Flexible/Karman Curette
• Catalog Number: 022012K
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	M803K022012 [Primary]

FDA Product Code

• HCY: Curette, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [MedGyn Flexible/Karman Cannula-Curette 11mm]

• M803K022012: 12mm Flexible/Karman Curette
• M803K022011: 11mm Flexible/Karman Curette