FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Temperature Sensor
DI: 07290015487061
·
Model: FAT8000000
·
ICECURE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Temperature Sensor
- Primary DI
- 07290015487061
- Version / Model
- FAT8000000
- Catalog Number
- FAT8000000
- Company Name
- ICECURE MEDICAL LTD
- Labeler DUNS
- 514758619
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-07
- Public Version
- 1
- Public Version Date
- 2022-06-15
- Public Version Status
- New
- Public Device Record Key
- de06aee0-9470-45c1-a6b3-dcd894607a4f
- Distribution End Date
- 2022-06-07
Device Description
Temperature Sensor - Use only with IceCure Cryogenic device
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 | Cryosurgical system temperature probe | A hand-held device intended to be used to monitor tissue temperature during a cryosurgical procedure, 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 cryosurgical 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 | 07290015487061 | GS1 |
Customer Contacts
- Phone
- +16468443066
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183213 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 170 | Millimeter | |
| Needle Gauge | 14 | Gauge |