FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGEA
DI: 06935650621319
·
Model: Exact HP-1805080U
·
Hygea Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGEA
- Primary DI
- 06935650621319
- Version / Model
- Exact HP-1805080U
- Company Name
- Hygea Medical Technology Co., Ltd.
- Labeler DUNS
- 549765730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-08
- Public Version
- 1
- Public Version Date
- 2025-09-16
- Public Version Status
- New
- Public Device Record Key
- 20107543-1e01-4258-820b-6b561bea7547
Device Description
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 66978 | Microwave ablation system probe, electrically-powered | An active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The probe includes a handle and a patient contact region (e.g., antenna, leaflets), and might include a cooling mechanism (via water irrigation) and/or thermocouple(s) to help control the temperature of the probe. The device is intended to be used in percutaneous, endoscopic (e.g., gastroscopic, laparoscopic), non-surgically invasive and open surgery procedures to ablate tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935650621319 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233140 | 000 |