FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGEA
DI: 06935650626468
·
Model: Ease TSL08A
·
Hygea Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGEA
- Primary DI
- 06935650626468
- Version / Model
- Ease TSL08A
- 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
- d9169ab6-c70b-414b-b935-eb125498c4c8
Device Description
The Sterile Temperature Probe is intended to be used in conjunction with the Exceed S10U microwave ablation device manufactured by Hygea Medical Technology Co., Ltd. to measure the temperature of solid tumors and surrounding tissues.
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 |
|---|---|---|---|---|
| 61287 | Microwave ablation system generator | A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935650626468 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233140 | 000 |