Sentimag

Basic Information

• Brand Name: Sentimag
• Primary DI: 15060391210312
• Version / Model: Gen 3
• Catalog Number: SMB03
• Company Name: ENDOMAGNETICS LTD
• Labeler DUNS: 846963171
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-09
• Public Version: 1
• Public Version Date: 2024-02-19
• Public Version Status: New
• Public Device Record Key: 225de6d6-30a6-4bc7-8d60-1d1cc0f3dfad

Device Description

Sentimag Gen 3 Base Unit

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: Yes
• 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
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	15060391210312	GS1

Premarket Submissions

Submission Number	Supplement Number
P160053	005