FDA UDI
In Commercial Distribution
🇺🇸 United States
HOTWIRE™ System RF Generator
DI: 00850057445251
·
Model: 903001
·
Atraverse Medical, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HOTWIRE™ System RF Generator
- Primary DI
- 00850057445251
- Version / Model
- 903001
- Catalog Number
- HB1
- Company Name
- Atraverse Medical, Inc
- Labeler DUNS
- 118954537
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-09
- Public Version
- 1
- Public Version Date
- 2025-09-17
- Public Version Status
- New
- Public Device Record Key
- 572e14f2-050f-48e7-bbb6-0db4c152601c
Device Description
The HOTWIRE™ System RF Generator is an AC mains power-operated device used with compatible, separately cleared RF puncture devices which are connected to the RF Generator through a HOTWIRE™ System Handpiece. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available neutral electrode, such as the Valleylab Model #E7507 (K822572). An optional HOTWIRE™ System Footswitch may be used with the RF Generator. Refer to Table 1 for the Model Numbers of the HOTWIRE™ System RF Generator and accessory devices covered by this application.
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
- 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
- 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 |
|---|---|---|---|---|
| 11490 | Electrosurgical system generator | An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850057445251 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252083 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 4.6 | Inch | |
| Length | 10.1 | Inch | |
| Width | 4.5 | Inch |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius