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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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MyCRO Band w/Lining purple
OTTO BOCK HEALTHCARE
24H1=11
In Commercial Distribution

  • 04064409000029 ()


  • Cranial orthosis
MyCRO Band w/Lining grey
OTTO BOCK HEALTHCARE
24H1=1
In Commercial Distribution

  • 04064409000012 ()


  • Cranial orthosis
The kinderBAND™ cranial remolding orthosis is a custom made orthotic device available by prescription only. It is used to treat infants between 3 and 18 months of age for asymmetrical head shapes such as positional plagiocephaly, brachycephaly and scaphocephaly.
BIOSCULPTOR CORPORATION
CL-4000
In Commercial Distribution

  • 00863457000302 ()
CL-4000

  • Cranial orthosis
The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
DANMAR PRODUCTS INC
9841
In Commercial Distribution

  • 00862948000302 ()


  • Cranial orthosis
Boston Band custom cranial remolding orthosis
Boston Brace International, Inc.
BB1
In Commercial Distribution

  • 00860010708101 ()


  • Cranial orthosis
Cranial Remolding Orthosis
Surestep, LLC
A8210
In Commercial Distribution

  • 00859065006034 ()


  • Cranial orthosis
Cranial Remolding Orthosis
Symbiont Logistics, LLC
A8210
In Commercial Distribution

  • 00859065006027 ()


  • Cranial orthosis
Cranial Remolding Orthosis
HANGER NATRIONAL LABORATORIES LLC
F8210
In Commercial Distribution

  • 00859065006003 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/Bi-Valve Opening
In Commercial Distribution

  • 00860013898076 ()


  • Cranial orthosis
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads.
INVENT MEDICAL USA LLC
Talee PostOp w/2in1/One-Side Opening
In Commercial Distribution

  • 00860013898069 ()


  • Cranial orthosis
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