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Specimen Orientation Charms, six distinctly shaped sterile 10mm charms
Specimen/Tissue, Identification Orientation
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code MJI?
Specimen/Tissue, Identification Orientation is FDA product code MJI, Class 1, 21 CFR 864.3010.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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