Locator, Magnetic
A magnetic locator is a device used in ophthalmic or surgical settings to detect the presence and location of magnetic foreign bodies within tissue, guiding their retrieval. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FTZ, regulated under 21 CFR 886.4445, within the Ophthalmic medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- FTZ
- Device Class
- FDA class 1
- Regulation Number
- 886.4445
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.