FDA UDI
In Commercial Distribution
🇺🇸 United States
DUALTO Energy System
DI: 20705036038402
·
Model: ETHEF1
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DUALTO Energy System
- Primary DI
- 20705036038402
- Version / Model
- ETHEF1
- Catalog Number
- ETHEF1
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 1
- Public Version Date
- 2025-06-26
- Public Version Status
- New
- Public Device Record Key
- 8e319fea-e6ba-412a-8b72-9cc42f415a71
Device Description
Energy Single Footswitch
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 |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30705036038409 | GS1 | CASE | 5 | In Commercial Distribution | |
| Primary | 20705036038402 | GS1 | ||||
| Direct Marking | 10705036038405 | GS1 |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243067 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius