FDA UDI
In Commercial Distribution
🇺🇸 United States
PROSENSE™ SYSTEM 100-127 VAC
DI: 07290015487290
·
Model: FAS3000000-2
·
ICECURE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROSENSE™ SYSTEM 100-127 VAC
- Primary DI
- 07290015487290
- Version / Model
- FAS3000000-2
- Catalog Number
- FAS3000000-2
- Company Name
- ICECURE MEDICAL LTD
- Labeler DUNS
- 514758619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-11
- Public Version
- 4
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- 65793ebc-f1b9-4df4-bb0c-a443aca20ccd
Device Description
PROSENSE™ SYSTEM 100-127 VAC Straight cryohandle
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | 878.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45738 | General cryosurgical system, cryogen gas, electronic | An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015487290 | GS1 |
Customer Contacts
- Phone
- 18889025716
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183213 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 47.24 | Inch | |
| Width | 19.68 | Inch | |
| Depth | 27.56 | Inch | |
| Weight | 150 | Kilogram |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 32 – 158 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Environment atmospheric pressure for Transportation and storage: between 500 and 1060 hPa