AccessGUDID - DEVICE: Sentimag SMP02 Probe Assembly (15060391210015)

GUDID

Device Identifier (DI) Information

Brand Name: Sentimag SMP02 Probe Assembly
Version or Model: SMP02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOMAGNETICS LTD

Primary DI Number: 15060391210015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 846963171 *Terms of Use

Device Description: Device Description: The Sentimag 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

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUV	Lymph Node Location System During Sentinel Biopsy Procedure
NEU	Marker, Radiographic, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: cf402d6c-ef27-4f9b-8e3b-f05be0393eaa
Public Version Date: March 25, 2024
Public Version Number: 2
DI Record Publish Date: June 20, 2023