Model: MTVC10-US
DI: 15060391210596
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a3e75418-fb99-48bc-906f-959faf823683
Distribution Status:
In Commercial Distribution
DUNS Number:
846963171
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
15060391210596
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60212
Name: Magnetic nanoparticle tracer
Definition:
A sterile, fluid magnetic material intended to be injected in close proximity to a tumour to facilitate its migration to sentinel lymph nodes; the lymph nodes can subsequently be localized with a magnetic field detector (magnetometer) and surgically removed for histological analysis. The device includes a suspension of dextran-coated iron oxide nanoparticles, available in a vial or syringe, that exhibit superparamagnetism in the presence of a magnetic field. It is typically used to support a variety of cancers, e.g., breast-, melanoma-, prostate-, or bowel cancer staging. This is a single-use device.
FDA Product Codes
PUV
Lymph Node Location System During Sentinel Biopsy Procedure
Premarket Submissions
Submission Number:
P160053
Supplement Number:
000