Locator, Magnetic

Device Code: 4136

Product Code(s): FTZ

Device Classification Information

Device Type ID4136
Device NameLocator, Magnetic
Regulation DescriptionPermanent Magnet.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.4445 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFTZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4136
DeviceLocator, Magnetic
Product CodeFTZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPermanent Magnet.
CFR Regulation Number886.4445 [🔎]
TPLC Last Update: 2019-04-02 20:43:37

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