FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NIKO SURG
DI: 10853512006209
·
Model: WR01
·
Leonhard Lang GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NIKO SURG
- Primary DI
- 10853512006209
- Version / Model
- WR01
- Catalog Number
- 2407
- Company Name
- Leonhard Lang GmbH
- Labeler DUNS
- 302846407
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2020-06-05
- Public Version Status
- Update
- Public Device Record Key
- 6f86130f-70c6-449a-8b2c-fd3285df22c3
- Distribution End Date
- 2018-02-05
Device Description
Neutral Electrodes
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58494 | Electrosurgical return electrode, single-use | A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30853512006203 | GS1 | case | 12 | Not in Commercial Distribution | 2018-02-05 |
| Package | 20853512006206 | GS1 | box | 100 | Not in Commercial Distribution | 2018-02-05 |
| Primary | 10853512006209 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius