FDA UDI
In Commercial Distribution
🇺🇸 United States
MedGyn Flexible/Karman Cannula-Curette 10mm
DI: M803K022010
·
Model: 10mm Flexible/Karman Curette
·
MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MedGyn Flexible/Karman Cannula-Curette 10mm
- Primary DI
- M803K022010
- Version / Model
- 10mm Flexible/Karman Curette
- Catalog Number
- 022010K
- Company Name
- MEDGYN PRODUCTS, INC.
- Labeler DUNS
- 103913430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-17
- Public Version
- 1
- Public Version Date
- 2025-04-25
- Public Version Status
- New
- Public Device Record Key
- e63c8b5e-a3d0-4941-b03d-587edf09e253
Device Description
10mm Flexible/Karman Curette
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HCY | Curette, Uterine | Obstetrics/Gynecology | 884.4530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M803K022010 | HIBCC |