FDA UDI
In Commercial Distribution
🇺🇸 United States
MedGyn Flexible/Karman Cannula-Curette 7mm
DI: M803K022007
·
Model: 7mm 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 7mm
- Primary DI
- M803K022007
- Version / Model
- 7mm Flexible/Karman Curette
- Catalog Number
- 022007K
- 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
- b3eac47a-1d56-4941-8aca-8ba4ef1045ee
Device Description
7mm 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 |
|---|---|---|---|---|
| 32655 | Intrauterine cannula, single-use | A sterile, semi-rigid or rigid, plastic or, less frequently metal, tube designed for insertion into the uterus. It is frequently connected directly or through an external tube or catheter to an irrigator and/or aspirator for irrigation, infusion, or withdrawal of substances. It may also provide a port through which instruments and/or probes are passed to perform a variety of gynaecologic/obstetric diagnostic, therapeutic, and surgical procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M803K022007 | HIBCC |