MedGyn Flexible/Karman Cannula-Curette 10mm 022010K

GUDID M803K022010

10mm Flexible/Karman Curette

MEDGYN PRODUCTS, INC.

Home-use peritoneal dialysis connection kit housing

• Primary Device ID: M803K022010
• NIH Device Record Key: e63c8b5e-a3d0-4941-b03d-587edf09e253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedGyn Flexible/Karman Cannula-Curette 10mm
• Version Model Number: 10mm Flexible/Karman Curette
• Catalog Number: 022010K
• 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	M803K022010 [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

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)