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Mercy Tape 2d And 3d Models

FDA product code PIR · 1 cleared devices

Class 1 General, Plastic Surgery
Regulation
21 CFR 878.4800
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2019-10-10 – 2019-10-10

The Mercy TAPE device (2D and 3D models) is intended for use by health care professionals to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the mid-upper arm circumference (MUAC).

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