FDA UDI
In Commercial Distribution
🇺🇸 United States
Vulvar Keyes Biopsy Punch Set
DI: M803030778
·
Model: Vulvar Keyes Biopsy Punch Set (Handle +6 Tips)
·
MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vulvar Keyes Biopsy Punch Set
- Primary DI
- M803030778
- Version / Model
- Vulvar Keyes Biopsy Punch Set (Handle +6 Tips)
- Catalog Number
- 030778
- Company Name
- MEDGYN PRODUCTS, INC.
- Labeler DUNS
- 103913430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-16
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- c96aedb2-eb80-417a-89ed-1e0bbef6e83a
Device Description
Vulvar Keyes Biopsy Punch Set (Handle +6 Tips)
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32594 | Intrauterine curette, manual | A heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M803030778 | HIBCC |