AccessGUDID - DEVICE: Magtrace (15060391210244)

GUDID

Device Identifier (DI) Information

Brand Name: Magtrace
Version or Model: MTVC10001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOMAGNETICS LTD

Primary DI Number: 15060391210244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 846963171 *Terms of Use

Device Description: Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60212	Magnetic nanoparticle tracer	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUV	Lymph Node Location System During Sentinel Biopsy Procedure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160053	000
P160053	002
P160053	005

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46b6178e-3809-48cf-8c5c-1d5856ea6f19
Public Version Date: March 25, 2024
Public Version Number: 3
DI Record Publish Date: June 20, 2023