FDA UDI
In Commercial Distribution
🇺🇸 United States
Swift Applicator Handpiece
DI: 05060652910022
·
Model: SWF-HP01
·
EMBLATION LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Swift Applicator Handpiece
- Primary DI
- 05060652910022
- Version / Model
- SWF-HP01
- Catalog Number
- SWF-HP01
- Company Name
- EMBLATION LIMITED
- Labeler DUNS
- 211334261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-02
- Public Version
- 1
- Public Version Date
- 2019-02-04
- Public Version Status
- New
- Public Device Record Key
- 6c5dc960-842a-4bcd-98c5-e61225608506
Device Description
The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.
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 |
|---|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40791 | Microwave hyperthermia system applicator, extracorporeal | A component of a microwave hyperthermia system designed to direct and deliver microwave energy used to produce a systemic or local heating effect. It is typically mounted on a floor, wall, or ceiling suspension that allows the operator to position the microwave source from a point outside the patient's body. The applicator assembly includes cables and connectors that interface with the energy-generating unit of the hyperthermia system during treatments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060652910022 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181941 | 000 |