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The STARlight® Bi-Valve 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 STARlight® Bi-Valve is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
703.01PA
In Commercial Distribution
- B15170301PA0 ()
703.01PA
- Cranial orthosis
The STARlight® Bi-Valve 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 STARlight® Bi-Valve is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
703.01A
In Commercial Distribution
- B15170301A0 ()
703.01A
- Cranial orthosis
Eye-Safe Laser Data Acquisition System that collects 3-D infant’s head shape data which is used for the fabrication of cranial orthoses.
Vorum Research Corporation
Series B
In Commercial Distribution
- B590507012000 ()
50-7012-00
- Cranial orthosis
No Description
CRANIAL TECHNOLOGIES, INC.
CRANIALHELMET
In Commercial Distribution
- B288CRANIALHELMET0 ()
CRANIALHELMET
- Cranial orthosis
No Description
R82 A/S
x:panda shape infant, no belt
In Commercial Distribution
- 05707292977021 ()
9001000002001
- Assistive ergonomic chair, manually-adjusted
No Description
R82 A/S
x:panda shape infant, w/belt
In Commercial Distribution
- 05707292975454 ()
9101000003001
- Assistive ergonomic chair, manually-adjusted
Finishing, shoulder shape,
diamond-coated tip 46 μm
Shoulder shape finishing line without risk
of a lesion in the attachment system,
and beginning of polishing thanks to its lower grit
diamond-coating
SATELEC
TIP PMS2
In Commercial Distribution
- 03609820022550 ()
F02255
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
No Description
Aktina Corp.
50-360
In Commercial Distribution
- B365503600 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-600
In Commercial Distribution
- B365116000 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-578
In Commercial Distribution
- B365115781 ()
- B365115780 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-577
In Commercial Distribution
- B365115771 ()
- B365115770 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-576
In Commercial Distribution
- B365115761 ()
- B365115760 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-575
In Commercial Distribution
- B365115751 ()
- B365115750 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-573
In Commercial Distribution
- B365115731 ()
- B365115730 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-571
In Commercial Distribution
- B365115710 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-570
In Commercial Distribution
- B365115700 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-565
In Commercial Distribution
- B365115651 ()
- B365115650 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-563
In Commercial Distribution
- B365115631 ()
- B365115630 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-562
In Commercial Distribution
- B365115620 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized
No Description
Aktina Corp.
11-561
In Commercial Distribution
- B365115610 ()
- Manual-aperture-control therapeutic x-ray system collimator, non-motorized