FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentimag Footswitch Assembly
DI: 15060391210022
·
Model: SMA
·
ENDOMAGNETICS LTD
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentimag Footswitch Assembly
- Primary DI
- 15060391210022
- Version / Model
- SMA
- Company Name
- ENDOMAGNETICS LTD
- Labeler DUNS
- 846963171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- 9a241036-6cb1-4f9e-99fd-65f5733d770a
Device Description
Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.
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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | General, Plastic Surgery | 878.4300 | 2 |
| PUV | Lymph Node Location System During Sentinel Biopsy Procedure | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12516 | Magnetic metal detector | A device designed to use the fluxmeter principle to detect the presence of metal in patients, such as metal fragments in wounds requiring removal or metallic implants prior to a magnetic resonance imaging (MRI) examination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060391210022 | GS1 |