FDA UDI
In Commercial Distribution
🇺🇸 United States
MarginProbe® Probe
DI: 07290012534034
·
Model: AC0300001
·
DILON MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MarginProbe® Probe
- Primary DI
- 07290012534034
- Version / Model
- AC0300001
- Company Name
- DILON MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 600832361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-21
- Public Version
- 1
- Public Version Date
- 2021-10-29
- Public Version Status
- New
- Public Device Record Key
- d6d0b8ba-7045-4d6f-a0af-888549b6b15f
Device Description
The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| OEE | Diagnostic Low Electric Field | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63373 | Intraoperative tumour margin analysis probe | A sterile electronic probe intended to be connected to a system analyser (not included) for tissue surface analysis and characterization using radio-frequency spectroscopy, to identify cancerous tissue at the cut-lines (margins) during a lumpectomy procedure. It includes a handpiece with a tissue contact tip and a cable which may include a suction line to allow complete tip/tissue contact. It is intended for systematic analysis of the tissue sample, whereby surfaces identified by the analyser as cancerous correspond to margins which may require further excision. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290012534034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110014 | 000 |