AccessGUDID - DEVICE: MedGyn Flexible/Karman Cannula-Curette 10mm (M803K022010)

GUDID

Device Identifier (DI) Information

Brand Name: MedGyn Flexible/Karman Cannula-Curette 10mm
Version or Model: 10mm Flexible/Karman Curette
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 022010K
Company Name: MEDGYN PRODUCTS, INC.

Primary DI Number: M803K022010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: 10mm Flexible/Karman Curette

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62655	Home-use peritoneal dialysis connection kit housing	A component of a peritoneal dialysis connection kit intended to function as a casing for elements used in a routine connection/disconnection between a peritoneal catheter and a dialysate line. It is a portable, closable, rigid housing with user interface levers/buttons designed to be manually manipulated to provide a mechanical connection/disconnection between the elements inside (e.g., premounted catheter adaptor, proximal end of the dialysate line), previously fitted in the housing by the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCY	Curette, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e63c8b5e-a3d0-4941-b03d-587edf09e253
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025