FDA UDI
In Commercial Distribution
🇺🇸 United States
Microwave Ablation Generator
DI: 06954414674453
·
Model: KY-2100A
·
Canyon Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Microwave Ablation Generator
- Primary DI
- 06954414674453
- Version / Model
- KY-2100A
- Company Name
- Canyon Medical Inc.
- Labeler DUNS
- 527310648
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 1
- Public Version Date
- 2025-03-24
- Public Version Status
- New
- Public Device Record Key
- e500f9d5-0764-4000-904a-7dbe1e6ca049
Device Description
Microwave Ablation Generator
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
- 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 |
|---|---|---|---|---|
| 40783 | Microwave hyperthermia system | A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06954414674453 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241827 | 000 |