Sentimag SMH02 Probe Holder

GUDID 25060391210012

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.

ENDOMAGNETICS LTD

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• Primary Device ID: 25060391210012
• NIH Device Record Key: b9c88565-8bc1-42c3-a930-cf9146e98fb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentimag SMH02 Probe Holder
• Version Model Number: SMH02
• Company DUNS: 846963171
• Company Name: ENDOMAGNETICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	25060391210012 [Primary]

FDA Product Code

• PUV: Lymph Node Location System During Sentinel Biopsy Procedure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by ENDOMAGNETICS LTD

• 15060391210329 - Sentimag: 2024-03-25 Standard Probe for Sentimag Gen 3
• 15060391210336 - Sentimag: 2024-03-25 Footswitch for Sentimag Gen 3
• 15060391210343 - Sentimag: 2024-03-25 Probe checker for Sentimag Gen 3 Probe
• 15060391210312 - Sentimag: 2024-03-22 Sentimag Gen 3 Base Unit
• 15060391210350 - Sentimag: 2024-03-22 Thin Probe for Sentimag Gen 3
• 15060391210008 - Sentimag Base Unit: 2023-06-28 The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected in
• 15060391210015 - Sentimag SMP02 Probe Assembly: 2023-06-28 Device Description: The Sentimag is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which i
• 15060391210022 - Sentimag Footswitch Assembly: 2023-06-28 Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is