FDA UDI
In Commercial Distribution
🇺🇸 United States
PlumePen
DI: 20845854061197
·
Model: PLPRO4020
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
20
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Basic Information
- Brand Name
- PlumePen
- Primary DI
- 20845854061197
- Version / Model
- PLPRO4020
- Catalog Number
- PLPRO4020
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-06-05
- Public Version
- 5
- Public Version Date
- 2026-04-17
- Public Version Status
- Update
- Public Device Record Key
- 4770c3b6-2476-4dc7-bb15-6b95449ea1c7
Device Description
PlumePen Pro Surgical Smoke Evacuation Pencil, 7/8" (22 mm), 10 ft. (3 m)
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
- Yes
- 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 | 30845854061194 | GS1 | Carton | 20 | In Commercial Distribution | |
| Primary | 20845854061197 | GS1 | ||||
| Unit of Use | 00845854061193 | GS1 | ||||
| Package | 40845854061191 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.875 | Inch | |
| Outer Diameter | 22 | Millimeter | |
| Length | 3 | Meter | |
| Length | 10 | Feet |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius