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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 black
OTTO BOCK HEALTHCARE
24H1=7
In Commercial Distribution

  • 04064409000081 ()


  • Cranial orthosis
MyCRO Band w/Lining blue
OTTO BOCK HEALTHCARE
24H1=5
In Commercial Distribution

  • 04064409000074 ()


  • Cranial orthosis
MyCRO Band w/Lining green
OTTO BOCK HEALTHCARE
24H1=3
In Commercial Distribution

  • 04064409000067 ()


  • Cranial orthosis
MyCRO Band w/Lining dark red
OTTO BOCK HEALTHCARE
24H1=2.5
In Commercial Distribution

  • 04064409000050 ()


  • Cranial orthosis
MyCRO Band w/Lining orange
OTTO BOCK HEALTHCARE
24H1=13
In Commercial Distribution

  • 04064409000043 ()


  • Cranial orthosis
MyCRO Band w/Lining pink
OTTO BOCK HEALTHCARE
24H1=12
In Commercial Distribution

  • 04064409000036 ()


  • Cranial orthosis
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
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/Bi-Valve Opening
In Commercial Distribution

  • 00860013898052 ()


  • 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/One-Side Opening
In Commercial Distribution

  • 00860013898045 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/Bi-Valve Opening
In Commercial Distribution

  • 00860013898038 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/2in1/One-Side Opening
In Commercial Distribution

  • 00860013898021 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/Bi-Valve Opening
In Commercial Distribution

  • 00860013898014 ()


  • Cranial orthosis
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic- shaped heads and combination of these defects.
INVENT MEDICAL USA LLC
Talee w/One-Side Opening
In Commercial Distribution

  • 00860013898007 ()


  • 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
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
ERGONOMIC HIGHLY RIGID PLASTIC RING HANDLE WITH STEPLESS RATCHET, RATCHET RELEASE/ ROTATION LEVER MODULE AND HIGH FREQUENCY
SONTEC INSTRUMENTS, INC.
2901-090
Not in Commercial Distribution

  • B09929010900 ()

  • FOR Ø3mm, Ø5mm & Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH BRANCHES & RATCHET ANGLED WITHOUT FLUSHING
SONTEC INSTRUMENTS, INC.
2901-086
Not in Commercial Distribution

  • B09929010860 ()

  • FOR 3mm, 5mm, 10mm Integral Needle Holder


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH BRANCHES & RATCHET ANGLED
SONTEC INSTRUMENTS, INC.
2901-084
Not in Commercial Distribution

  • B09929010840 ()

  • FOR 3mm, 5mm, 10mm Integral Needle Holder


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH SPRING & RATCHET ANGLED
SONTEC INSTRUMENTS, INC.
2901-082
Not in Commercial Distribution

  • B09929010820 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH SPREADING SPRING
SONTEC INSTRUMENTS, INC.
2901-080
Not in Commercial Distribution

  • B09929010800 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH BRANCHES & RATCHET
SONTEC INSTRUMENTS, INC.
2901-078
Not in Commercial Distribution

  • B09929010780 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL HANDLE WITH SPRING & RATCHET
SONTEC INSTRUMENTS, INC.
2901-076
Not in Commercial Distribution

  • B09929010760 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL RING HANDLE WITHOUT RATCHET
SONTEC INSTRUMENTS, INC.
2901-074
Not in Commercial Distribution

  • B09929010740 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL RING HANDLE WITH RATCHET
SONTEC INSTRUMENTS, INC.
2901-072
Not in Commercial Distribution

  • B09929010720 ()

  • FOR 3mm, 5mm, 10mm Integral Needle Holder


  • Laparoscopic surgical procedure kit, non-medicated, reusable
AXIAL RING HANDLE WITH RATCHET
SONTEC INSTRUMENTS, INC.
2901-070
Not in Commercial Distribution

  • B09929010700 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD, RATCHET & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-066
Not in Commercial Distribution

  • B09929010660 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
INSULATED METAL HANDLE ANGLED WITH ROTATING HEAD & HIGH FREQUENCY CONNECTOR
SONTEC INSTRUMENTS, INC.
2901-064
Not in Commercial Distribution

  • B09929010640 ()

  • FOR Ø3mm, Ø5mm, Ø10mm TUBE SHAFT INSTRUMENTS


  • Laparoscopic surgical procedure kit, non-medicated, reusable
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