FDA UDI
In Commercial Distribution
🇺🇸 United States
SuperCut Hysterectomy Scissors
DI: 00888937026641
·
Model: SC16260
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SuperCut Hysterectomy Scissors
- Primary DI
- 00888937026641
- Version / Model
- SC16260
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 0149a119-0792-4bb1-98d6-8630a29296e1
Device Description
SuperCut Hysterectomy Scissors- Slight curve - Length 260 mm
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35328 | Gynaecological scissors, reusable | A hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937026641 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 260 | Millimeter |