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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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Poly-Axial Screw Assembly, Solid, Ø5.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020705 ()
3PS55-45

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø5.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020699 ()
3PS55-40

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø5.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020682 ()
3PS55-35

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø5.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020675 ()
3PS55-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 45mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020668 ()
3PS45-45

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 40mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020651 ()
3PS45-40

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 35mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020644 ()
3PS45-35

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 30mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020637 ()
3PS45-30

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 25mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020620 ()
3PS45-25

  • Bone-screw internal spinal fixation system, non-sterile
Poly-Axial Screw Assembly, Solid, Ø4.5mm x 20mm
NEW ERA ORTHOPEDICS LLC
B
In Commercial Distribution

  • 00815730020613 ()
3PS45-20

  • Bone-screw internal spinal fixation system, non-sterile
A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations. Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.
Taub Products
B
In Commercial Distribution

  • D8370620100 ()

  • Total Volume: 6 Milliliter
06-2010

  • Dental repair kit, ceramic
No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
B
In Commercial Distribution

  • 01081019001805 ()
16341

  • Cast cutting shears
No Description
TILLA CARE LTD
B
In Commercial Distribution

  • 07290109270197 ()
MEC00003

  • Urine transfer IVD, non-sterile
No Description
TILLA CARE LTD
B
In Commercial Distribution

  • 07290109270036 ()
KIT00005

  • Urine transfer IVD, non-sterile
No Description
TILLA CARE LTD
B
In Commercial Distribution

  • 07290109270029 ()
FPR00001

  • Urine transfer IVD, non-sterile
No Description
Jiangsu HanHeng Medical Technology Co., Ltd
B
In Commercial Distribution

  • 06973697810525 ()


  • General-purpose absorbent tip applicator/swab, single-use
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
XACT ACE Xtend
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702384 ()
XR-ACE-XTEND

  • Computer/medical device keyboard
Attachment Frame
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702285 ()
XR-ATT-FRM

  • Radiological general body-part positioner
Aiming Plate Drape
XACT ROBOTICS LTD
B
In Commercial Distribution

  • 07290017702247 ()
XR-AP-DRP

  • Medical equipment/instrument drape, single-use
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