FDA UDI
In Commercial Distribution
🇺🇸 United States
Swaroplate
DI: 15060441919288
·
Model: 1211H
·
NISSHA MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Swaroplate
- Primary DI
- 15060441919288
- Version / Model
- 1211H
- Catalog Number
- 6000790N
- Company Name
- NISSHA MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 671405566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-29
- Public Version
- 1
- Public Version Date
- 2021-05-07
- Public Version Status
- New
- Public Device Record Key
- 83c2dc52-8981-4cef-873e-ceb3f5701e85
Device Description
Neutral Electrode
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
- Yes
- 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
- Yes
- 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 | 35060441919282 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 15060441919288 | GS1 | ||||
| Package | 55060441919286 | GS1 | Case | 300 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203494 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius