FDA UDI
In Commercial Distribution
🇺🇸 United States
LEEP Macro Needle Electrode
DI: 00888937010732
·
Model: N1200
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LEEP Macro Needle Electrode
- Primary DI
- 00888937010732
- Version / Model
- N1200
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 6
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 1941763c-8fba-415d-b671-d24f82142664
Device Description
LEEP Macro Needle Electrode with 16mm Needle Electrode and 12cm Shaft
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937010736 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00888937010732 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905747 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.8mm Diameter |