FDA UDI
In Commercial Distribution
🇺🇸 United States
EXABLATE PROSTATE Treatment master kit for V2.2
DI: 07290019402268
·
Model: PROSTATE WATERLESS MASTER KIT FOR 5 TREATMENTS (FDA/NON-CE)
·
INSIGHTEC LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EXABLATE PROSTATE Treatment master kit for V2.2
- Primary DI
- 07290019402268
- Version / Model
- PROSTATE WATERLESS MASTER KIT FOR 5 TREATMENTS (FDA/NON-CE)
- Catalog Number
- SET001653
- Company Name
- INSIGHTEC LTD
- Labeler DUNS
- 532169513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-15
- Public Version
- 2
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 78a6dbc1-476f-4fc2-abdc-234f62af63ec
Device Description
Prostate v2.2 single use master kit for 5 treatments
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | Gastroenterology, Urology | 876.4340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57888 | Therapeutic oncological/gynaecological ultrasound system | An assembly of electrically-powered devices designed to treat solid tumours of hard (bone) and/or soft tissue [e.g., liver, kidney, breast, prostate] and/or gynaecological disorders (e.g., uterine fibroid, adenomyosis) through noninvasive or non-surgically invasive localized application of high intensity focused ultrasound (HIFU) or high intensity therapeutic ultrasound (HITU) intended to gradually denature/ablate tissue lesions. It typically consists of a piezoelectric transducer (probe), a water supply/power control unit, operator console and monitoring systems, software, and sometimes a patient table. Optimal patient positioning is achieved using an ultrasound scanner or MRI system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019402268 | GS1 |
Customer Contacts
- Phone
- 18663922528
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 25 Degrees Celsius