Specimen/Tissue, Identification Orientation
The Specimen and Tissue Identification Orientation device is a pathology accessory used to maintain the spatial orientation of surgical tissue specimens during transport to the pathology laboratory and processing, ensuring that the relationship between anatomical margins and the tissue sample is preserved for accurate histological assessment. Classified as a Class 1 device under 21 CFR 864.3010 within the Pathology specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJI
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.