FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVA LED Light Source Pencil
DI: HS101125
·
Model: Hand Switching
·
Pare Surgical, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NOVA LED Light Source Pencil
- Primary DI
- HS101125
- Version / Model
- Hand Switching
- Catalog Number
- 900018
- Company Name
- Pare Surgical, Inc
- Labeler DUNS
- 949432546
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-15
- Public Version
- 3
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 608adffa-dcdb-47f1-99ed-f9102856ee31
Device Description
The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal end for better visualization of the surgical field. The NOVA can be fitted with a smoke shroud that will remove the smoke plume from the site.The device is designed to work with all standard Electrosurgical Generators.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61869 | Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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 |
|---|---|---|---|---|---|---|
| Primary | HS101125 | HIBCC | ||||
| Package | HS112ESUPENCILS | HIBCC | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- 13036890187
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 120 Degrees Fahrenheit