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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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HOOK ELECTRODE BIPO 22-26FR 12/30° for resectoscope, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation 22/24/26Fr, electrode shape: hook, PACK=1 PC, for Shark Resectoscopes, branch color: blue, stem color: yellow, unsterile, reusable
Richard Wolf GmbH
862309
In Commercial Distribution

  • 04055207010792 ()
862309

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
KNIFE ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: knife, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
842719
Not in Commercial Distribution

  • 04055207010204 ()
8427.19

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
COAG ELECTRODE MONO 26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 26/28, Fr, electrode shape: roller, fork color white, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
842702
Not in Commercial Distribution

  • 04055207010198 ()
8427.02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
ROLLER ELECTRODE MONO 21/24.5FR for hysteroscopy, for continuous irrigation sheaths, 21/ 24.5, Fr, electrode shape: roller, fork color red, stem color blue, PACK=1 PC, for use in combination with the Princess resectoscope, unsterile, reusable
Richard Wolf GmbH
865302
Not in Commercial Distribution

  • 04055207040744 ()
8653.02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
No Description
CRANIAL TECHNOLOGIES, INC.
CRANIALHELMET
In Commercial Distribution

  • B288CRANIALHELMET0 ()
CRANIALHELMET

  • 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.
762.01A
In Commercial Distribution

  • B15176201A0 ()
762.01A

  • Cranial orthosis
The STARband® 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® 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 a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
761PA
In Commercial Distribution

  • B151761PA0 ()
761PA

  • Cranial orthosis
The STARband® 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® 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 a side opening design and is held in place by a Velcro® strap across the side opening.
ORTHOMERICA PRODUCTS, INC.
761A
In Commercial Distribution

  • B151761A0 ()
761A

  • Cranial orthosis
The STARband® Plus 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.
ORTHOMERICA PRODUCTS, INC.
761.09PA
In Commercial Distribution

  • B15176109PA0 ()
761.09PA

  • Cranial orthosis
The STARband® Plus 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.
ORTHOMERICA PRODUCTS, INC.
761.09A
In Commercial Distribution

  • B15176109A0 ()
761.09A

  • Cranial orthosis
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