FDA UDI
In Commercial Distribution
🇺🇸 United States
MediMax Tech
DI: 00817325020831
·
Model: DBNH Push Button ESU Pencil
·
MEDIMAX TECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediMax Tech
- Primary DI
- 00817325020831
- Version / Model
- DBNH Push Button ESU Pencil
- Company Name
- MEDIMAX TECH INC.
- Labeler DUNS
- 927071162
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4aa93b7f-b127-47a9-9910-5738fd9d6c45
Device Description
DBNH Push Button ESU Pencil - 2.5'' Stainless & Coated Blade, Holster, ESU Pencil, 10'' Cable
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
- Yes
- 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 |
|---|---|---|---|---|
| 61870 | Open-surgery electrosurgical handpiece/electrode, monopolar, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817325020835 | GS1 | Master Case | 2 | In Commercial Distribution | |
| Package | 10817325020838 | GS1 | Inner Box | 25 | In Commercial Distribution | |
| Primary | 00817325020831 | GS1 |
Customer Contacts
- Phone
- 855-633-4629
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092732 | 000 |