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The STARlight® PRO is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended 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® PRO is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding and/or Reston (polyurethane) foam. It utilizes two side openings and is held in place by a Velcro® straps across the side openings.
ORTHOMERICA PRODUCTS, INC.
762.07PA
In Commercial Distribution
- B15176207PA0 ()
762.07PA
- Cranial orthosis
The STARband® 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 STARband® Bi-Valve is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
762.06PA
In Commercial Distribution
- B15176206PA0 ()
762.06PA
- Cranial orthosis
The STARband® 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 STARband® Bi-Valve is made with an outer copolymer plastic shell and an inner liner made of pelite polyethylene foam or Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
762.06A
In Commercial Distribution
- B15176206A0 ()
762.06A
- Cranial orthosis
The STARlight® 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® is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
762.03PA
In Commercial Distribution
- B15176203PA0 ()
762.03PA
- Cranial orthosis
The STARlight® 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® is made of clear Surlyn plastic or clear co-polyester plastic and may contain optional Aliplast foam (closed cell polyethylene) padding. It utilizes a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
762.03A
In Commercial Distribution
- B15176203A0 ()
762.03A
- 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.
762.01PA
In Commercial Distribution
- B15176201PA0 ()
762.01PA
- Cranial orthosis
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET/RATCHET ACTIVATING-DEACTIVATING KEY/
ROTATION MODULE AND HIGH FREQUENCY CONNECTION
SONTEC INSTRUMENTS, INC.
2901-098
Not in Commercial Distribution
- B09929010980 ()
- FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
- Laparoscopic surgical procedure kit, non-medicated, reusable
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH ROTATION MODULE AND HIGH FREQUENCY CONNECTION
SONTEC INSTRUMENTS, INC.
2901-096
Not in Commercial Distribution
- B09929010960 ()
- FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
- Laparoscopic surgical procedure kit, non-medicated, reusable
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH RATCHET/RATCHET ACTIVATING/RELEASE LEVER, ROTATION MODULE AND HIGH FREQUENCY
SONTEC INSTRUMENTS, INC.
2901-094
Not in Commercial Distribution
- B09929010940 ()
- FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
- Laparoscopic surgical procedure kit, non-medicated, reusable
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RATCHET/RELEASE KEY, ROTATION MODULE AND HIGH FREQUENCY
SONTEC INSTRUMENTS, INC.
2901-092
Not in Commercial Distribution
- B09929010920 ()
- FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS
- Laparoscopic surgical procedure kit, non-medicated, reusable