FDA UDI
In Commercial Distribution
🇺🇸 United States
Margin Probe Console 2.0
DI: 07290012534065
·
Model: SA0590040
·
DILON MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Margin Probe Console 2.0
- Primary DI
- 07290012534065
- Version / Model
- SA0590040
- Company Name
- DILON MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 600832361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-15
- Public Version
- 1
- Public Version Date
- 2025-10-23
- Public Version Status
- New
- Public Device Record Key
- 3e28db34-e096-418c-ba53-568f3174100f
Device Description
The MARGINPROBE 2.0 System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| OEE | Diagnostic Low Electric Field | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63372 | Intraoperative tumour margin analyser | A mains electricity (AC-powered) unit designed for tissue surface analysis and characterization using radio-frequency (RF) spectroscopy, to identify cancerous tissue at the cut-lines (margins) during a lumpectomy procedure. It includes RF spectroscopy hardware, a monitor, and may include a suction pump to allow complete tissue contact; it is intended to be used with a dedicated probe (not included). Results are characterized (e.g., cancerous/non-cancerous) and displayed/labelled graphically (e.g., posterior, anterior, inferior, superior, medial, lateral), whereby surfaces identified as cancerous correspond to margins which may require further excision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290012534065 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110014 | 013 |