SEARCH RESULTS FOR: (*EPS Shape Moulding Machine*)(133767 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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P-POD - 00196852667895

P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.
PPOD Orthotics Inc.
DD-1930
In Commercial Distribution

  • 00196852667895 ()
DD-1930

  • Cranial orthosis

MyCRO Band - 04064409000104

MyCRO Band w/Lining beige
OTTO BOCK HEALTHCARE
24H1=9
In Commercial Distribution

  • 04064409000104 ()


  • Cranial orthosis

MyCRO Band - 04064409000098

MyCRO Band w/Lining brown
OTTO BOCK HEALTHCARE
24H1=8
In Commercial Distribution

  • 04064409000098 ()


  • Cranial orthosis

MyCRO Band - 04064409000081

MyCRO Band w/Lining black
OTTO BOCK HEALTHCARE
24H1=7
In Commercial Distribution

  • 04064409000081 ()


  • Cranial orthosis

MyCRO Band - 04064409000074

MyCRO Band w/Lining blue
OTTO BOCK HEALTHCARE
24H1=5
In Commercial Distribution

  • 04064409000074 ()


  • Cranial orthosis

MyCRO Band - 04064409000067

MyCRO Band w/Lining green
OTTO BOCK HEALTHCARE
24H1=3
In Commercial Distribution

  • 04064409000067 ()


  • Cranial orthosis

MyCRO Band - 04064409000050

MyCRO Band w/Lining dark red
OTTO BOCK HEALTHCARE
24H1=2.5
In Commercial Distribution

  • 04064409000050 ()


  • Cranial orthosis

MyCRO Band - 04064409000043

MyCRO Band w/Lining orange
OTTO BOCK HEALTHCARE
24H1=13
In Commercial Distribution

  • 04064409000043 ()


  • Cranial orthosis

MyCRO Band - 04064409000036

MyCRO Band w/Lining pink
OTTO BOCK HEALTHCARE
24H1=12
In Commercial Distribution

  • 04064409000036 ()


  • Cranial orthosis

MyCRO Band - 04064409000029

MyCRO Band w/Lining purple
OTTO BOCK HEALTHCARE
24H1=11
In Commercial Distribution

  • 04064409000029 ()


  • Cranial orthosis
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