FDA UDI
In Commercial Distribution
🇺🇸 United States
Valleylab
DI: 10884521104211
·
Model: FORCEARGONII20ZD
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Valleylab
- Primary DI
- 10884521104211
- Version / Model
- FORCEARGONII20ZD
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-22
- Public Version
- 6
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 4eb380b5-0db3-4b19-ab67-ad3260356da9
Device Description
Argon Gas Delivery Unit II 120 V
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 36155 | Inert gas-enhanced electrosurgical system generator | An electrically-powered component of an inert gas-enhanced electrosurgical system that serves as the source of inert gas [e.g., argon (Ar), helium (He)] and generates a high frequency electrical current in selected radio-frequency (RF) bands between two electrodes to produce heat in tissues for cutting and coagulating during surgery. The gas is delivered via this device and through a connected handpiece unit that ensures that the gas is channelled around the cutting electrode; a process which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10884521104211 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964636 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity