FDA UDI
In Commercial Distribution
🇺🇸 United States
HYGEA
DI: 06935650602042
·
Model: Ease TSS08
·
Hygea Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYGEA
- Primary DI
- 06935650602042
- Version / Model
- Ease TSS08
- 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
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- c8b6b2f3-e74b-4086-863b-b8008cd390f8
Device Description
The Sterile Temperature Probe is intended to be used in conjunction with the Co-Ablation System to measure the temperature of solid tumors excluding the cavity 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 |
|---|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 878.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65125 | Surgical ablation temperature probe | A hand-held device intended to be used to monitor tissue temperature during a surgical ablation procedure (e.g., cryosurgical, microwave, or radio-frequency ablation), typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the surgical ablation system control unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06935650602042 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243042 | 000 |