FDA UDI
In Commercial Distribution
🇺🇸 United States
Kevorkian Curette
DI: 00888937017373
·
Model: 66-442
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kevorkian Curette
- Primary DI
- 00888937017373
- Version / Model
- 66-442
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-08
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 776bd6ec-a4bf-4f95-ab09-3f5ef94b4cd1
Device Description
Kevorkian Curette with basket
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46871 | Endometrial biopsy curette | A hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937017373 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 305 | Millimeter |