FDA UDI
In Commercial Distribution
🇺🇸 United States
Olympus
DI: 06939029815118
·
Model: WA98210R
·
Modern Medical Equipment MFG. Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Olympus
- Primary DI
- 06939029815118
- Version / Model
- WA98210R
- Company Name
- Modern Medical Equipment MFG. Ltd.
- Labeler DUNS
- 527812392
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-31
- Public Version
- 3
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- 84cb47e0-d6db-45d4-8d6c-28c922f5f7fa
Device Description
Disposable Rocker Switch Pencil ,Coated Electrode Blade.White color of pencil with 3m color blue Cable ,3 prong plug .Standard hex over mold blade with Teflon Coated
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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 36939029815119 | GS1 | Shipping Carton | 100 | In Commercial Distribution | |
| Package | 16939029815115 | GS1 | Dispensary Box | 10 | In Commercial Distribution | |
| Primary | 06939029815118 | GS1 | ||||
| Package | 26939029815112 | GS1 | Inner Box | 50 | In Commercial Distribution |