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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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Rod, Curved, Co-Cr, Ø5.5mm x 80mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020538 ()
3RCC55-80

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 70mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020514 ()
3RCC55-70

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020484 ()
3RCC55-50

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020460 ()
3RCC55-40

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020446 ()
3RCC55-30

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Co-Cr, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020439 ()
3RCC55-25

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Titanium, Ø5.5mm x 150mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020422 ()
3RCT55-150

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Titanium, Ø5.5mm x 140mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020415 ()
3RCT55-140

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Titanium, Ø5.5mm x 130mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020408 ()
3RCT55-130

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Titanium, Ø5.5mm x 100mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020378 ()
3RCT55-100

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Curved, Titanium, Ø5.5mm x 75mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020347 ()
3RCT55-75

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 60mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020088 ()
3RST55-60

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 55mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020071 ()
3RST55-55

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium,Ø5.5mm x 50mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020064 ()
3RST55-50

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium,Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020057 ()
3RST55-45

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020033 ()
3RST55-35

  • Trans-facet-screw internal spinal fixation system, sterile
Rod, Straight, Titanium, Ø5.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
A
In Commercial Distribution

  • 00815730020019 ()
3RST55-25

  • Trans-facet-screw internal spinal fixation system, sterile
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
350
In Commercial Distribution

  • 00892064002355 ()

  • Area/Surface Area: 350 Square millimeter
CP350

  • Glaucoma shunt, tubular, non-animal-derived
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST350
In Commercial Distribution

  • 00892064002096 ()

  • Area/Surface Area: 350 Square millimeter
10-0610

  • Glaucoma shunt, tubular, non-animal-derived
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

  • Area/Surface Area: 250 Square millimeter
10-0609

  • Glaucoma shunt, tubular, non-animal-derived
No Description
NEW ERIE SCIENTIFIC LLC
Cover Slips
In Commercial Distribution

  • 10810041333985 ()
  • 00810041333988 ()
BB02400500P113MNZ1

  • Microscope slide coverslip IVD
Pediatric Polypropylene Glaucoma Drainage Device
NEW WORLD MEDICAL, INCORPORATED
S3
Not in Commercial Distribution

  • 00892064002140 ()

  • Area/Surface Area: 85 Square millimeter
S3

  • Eye valve
Ahmed Accessory Tube Extender
NEW WORLD MEDICAL, INCORPORATED
TE
In Commercial Distribution

  • 00892064002188 ()

  • Length: 4.8 Millimeter
  • Width: 3 Millimeter
TE

  • Glaucoma shunt, tubular, non-animal-derived
DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.
OTC DENTAL CORPORATION
DSF212.00
In Commercial Distribution

  • 00863995000109 ()


  • Denture reliner, soft, home-use
ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS
PENTAX OF AMERICA, INC.
90075
In Commercial Distribution

  • 04961333241392 ()


  • Constant-voltage transformer
Isolation Transformer
PENTAX OF AMERICA, INC.
9175
In Commercial Distribution

  • 04961333230334 ()


  • Constant-voltage transformer
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
4c
In Commercial Distribution

  • 00852305002070 ()


  • Denture reliner, soft, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution

  • 00852305002018 ()


  • Denture reliner, soft, home-use
Noise Reduction Transformer, 100V
ST. JUDE MEDICAL, INC.
H702490
In Commercial Distribution

  • 05415067024909 ()
H702490

  • Constant-voltage transformer
Noise Reduction Transformer, 120V
ST. JUDE MEDICAL, INC.
H702484
In Commercial Distribution

  • 05415067024848 ()
H702484

  • Constant-voltage transformer
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