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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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Green X 12 - 08800016401844

PHT-75CHS(RC12X8.5)(US)/P(W-PAN P)+C(W-CEPH)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401844 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 12 - 08800016401837

PHT-75CHS(SP12X8.5)(US)/P(W-PAN P)+CT(W-PAN P)+TUBE/MASTER Green X 12 (Model: PHT-75CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography, Green X 12 is a complete digital X-ray system equipped with imaging viewers, an X-ray generator, and a dedicated SSXI detector.
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016401837 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400793

Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1524CF Master Plus OP, Xmaru2602CF/W-Ceph(P)/MASTER
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400793 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

Green X 18 - 08800016400786

Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition Xmaru1524CF Master Plus OP
VATECH CO., LTD.
PHT-75CHS
In Commercial Distribution

  • 08800016400786 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

iN∫X ® - 00190790001339

iN∫X ® for iN∫Line™, Integrated Patient Transport & Loading System – DWL
FERNO-WASHINGTON, INC.
0015811
In Commercial Distribution

  • 00190790001339 ()


  • Ambulance stretcher, electrohydraulic

iN∫X ® - 00190790001322

iN∫X ® for 175, Integrated Patient Transport & Loading System – DWL,SX
FERNO-WASHINGTON, INC.
0015810
Not in Commercial Distribution

  • 00190790001322 ()


  • Ambulance stretcher, electrohydraulic

iN∫X ® - 00190790001308

iN∫X ® for 175, Integrated Patient Transport & Loading System – DWL
FERNO-WASHINGTON, INC.
0015808
Not in Commercial Distribution

  • 00190790001308 ()


  • Ambulance stretcher, electrohydraulic

iN∫X® - 00190790000004

iN∫X® for iN∫Line™, Integrated Patient Transport & Loading System
FERNO-WASHINGTON, INC.
0015803
In Commercial Distribution

  • 00190790000004 ()


  • Ambulance stretcher, electrohydraulic

Implant Analog (X) - 00841549117374

Stainless Steel. Used to replicate the position of the implant in a working implant cast. Made from Stainless steel.
STERNGOLD DENTAL LLC
904547
In Commercial Distribution

  • 00841549117374 ()


  • Dental implant analog

RESORB X, STERILE - 10888118101089

SCREW, PDLLA
KLS-Martin L.P.
52-022-25-04
In Commercial Distribution

  • 10888118101089 ()
  • 00888118101082 ()

  • 2.1 X 5 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118101072

SCREW, PDLLA
KLS-Martin L.P.
52-022-24-04
In Commercial Distribution

  • 10888118101072 ()
  • 00888118101075 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000085

SCREW, PDLLA
KLS-Martin L.P.
52-024-27-04
In Commercial Distribution

  • 10888118000085 ()
  • 00888118000088 ()

  • 2.4 X 7 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000078

SCREW, PDLLA
KLS-Martin L.P.
52-024-25-04
In Commercial Distribution

  • 10888118000078 ()
  • 00888118000071 ()

  • 2.4 X 5 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000061

SCREW, PDLLA
KLS-Martin L.P.
52-021-29-04
In Commercial Distribution

  • 10888118000061 ()
  • 00888118000064 ()

  • 2.1 X 9 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000054

SCREW, PDLLA
KLS-Martin L.P.
52-021-27-04
In Commercial Distribution

  • 10888118000054 ()
  • 00888118000057 ()

  • 2.1 X 7 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000047

SCREW, PDLLA
KLS-Martin L.P.
52-021-24-04
In Commercial Distribution

  • 10888118000047 ()
  • 00888118000040 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000030

SCREW, PDLLA
KLS-Martin L.P.
52-020-57-04
In Commercial Distribution

  • 10888118000030 ()
  • 00888118000033 ()

  • 2.1 X 7 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000023

SCREW, PDLLA
KLS-Martin L.P.
52-020-55-04
In Commercial Distribution

  • 10888118000023 ()
  • 00888118000026 ()

  • 2.1 X 5 MM


  • Craniofacial bone screw, bioabsorbable

RESORB X, STERILE - 10888118000016

SCREW, PDLLA
KLS-Martin L.P.
52-020-54-04
In Commercial Distribution

  • 10888118000016 ()
  • 00888118000019 ()

  • 2.1 X 4 MM


  • Craniofacial bone screw, bioabsorbable

“X” Osteotome, 7mm - 00847538006360

“X” Osteotome, 7mm
SYMMETRY MEDICAL INC.
10-008-400
In Commercial Distribution

  • 00847538006360 ()
2709-01-010

  • Orthopaedic osteotome
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