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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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Linear ST, 50cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-50
In Commercial Distribution

  • M365SC2218500 ()

  • 50 cm Length
SC-2218-50

  • Analgesic spinal cord electrical stimulation system
Linear ST, 30cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-30
In Commercial Distribution

  • M365SC2218300 ()

  • 30 cm Length
SC-2218-30

  • Analgesic spinal cord electrical stimulation system
No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated
St. Jude Medical Probe Covers Clear Polyethylene Non-Sterile 9in x 96in x 1in 100 per Case
TIDI PRODUCTS, LLC
33431
Not in Commercial Distribution

  • 01618125183882 ()


  • Medical equipment/instrument drape, single-use
St. Jude Medical Probe Covers Clear Polyethylene Sterile 9in x 96in x 1in 100 per Case
TIDI PRODUCTS, LLC
30965
Not in Commercial Distribution

  • 00618125167883 ()
  • 01618125167882 ()


  • Medical equipment/instrument drape, single-use
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
763.08PA
In Commercial Distribution

  • B15176308PA0 ()
763.08PA

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
763.08A
In Commercial Distribution

  • B15176308A0 ()
763.08A

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
709.08PA
In Commercial Distribution

  • B15170908PA0 ()
709.08PA

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
709.08A
In Commercial Distribution

  • B15170908A0 ()
709.08A

  • Cranial orthosis
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
704.08PA
In Commercial Distribution

  • B15170408PA0 ()
704.08PA

  • Cranial orthosis
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