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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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4 Inch Fechtner Conjunctiva Titanium Forceps, Very Delicate Ring Shape Tips, Serrated Handle
Surgical Direct, Inc.
S36629-31T
In Commercial Distribution

  • B382S3662931T0 ()
S36629-31T

  • Dressing/utility forceps, scissors-like, reusable
Cannula, Multi Hole 6, Infiltration, specify length, diameter, tip shape and handle/hub
The Wells Johnson Company
20121800
In Commercial Distribution

  • B458201218000 ()
20-1218-00

  • Liposuction system cannula, reusable
Cannula, Micro 3-Port Radial, on dll hub, specify length, diameter and tip shape
The Wells Johnson Company
20150900
In Commercial Distribution

  • B458201509000 ()
20-1509-00

  • Liposuction system cannula, reusable
Cannula, Del Vecchio 12-Hole (new), specify length, diameter, tip shape and handle/hub
The Wells Johnson Company
20134400
In Commercial Distribution

  • B458201344000 ()
20-1344-00

  • Liposuction system cannula, reusable
No Description
CRANIAL TECHNOLOGIES, INC.
CRANIALHELMET
In Commercial Distribution

  • B288CRANIALHELMET0 ()
CRANIALHELMET

  • Cranial orthosis
The STARband® 3D 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.
ORTHOMERICA PRODUCTS, INC.
766.10A
In Commercial Distribution

  • B15176610A0 ()
766.10A

  • 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.
766.09PA
In Commercial Distribution

  • B15176609PA0 ()
766.09PA

  • 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.
766.09A
In Commercial Distribution

  • B15176609A0 ()
766.09A

  • Cranial orthosis
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.
766.07PA
In Commercial Distribution

  • B15176607PA0 ()
766.07PA

  • 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.
766.06PA
In Commercial Distribution

  • B15176606PA0 ()
766.06PA

  • Cranial orthosis
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