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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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No Description
CAYENNE MEDICAL, INC.
CM-6201
In Commercial Distribution

  • M543CM6201 ()
CM-6201

  • Bone tap, reusable
surgical instrument or accessory for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FIS 611
In Commercial Distribution

  • 00840118106832 ()


  • Surgical instrument/implant depth limiter, reusable
No Description
NARVA Lichtquellen GmbH + Co KG.
F12 T5 15W PH / BiPin
Not in Commercial Distribution

  • 84014501000027 ()
  • 54014501500021 ()
  • 04014501000021 ()
10044

  • Ultraviolet tanning device
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
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
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
Coronary Imaging Catheter
BOSTON SCIENTIFIC CORPORATION
H74939405010
Not in Commercial Distribution

  • 08714729893240 ()

  • 135 cm Effective Length
  • 1.00 mm Diameter
  • 3.0 F Diameter


  • Intravascular ultrasound imaging catheter, single-use
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
GRYPHON FLEX X DISPOSABLE INSTRUMENT KIT
Medos International Sàrl
271079
In Commercial Distribution

  • 10886705033294 ()
271079

  • Orthopaedic surgical procedure kit, non-medicated, single-use
GRYPHON FLEX X DRILL REUSABLE
Medos International Sàrl
271076
In Commercial Distribution

  • 10886705033263 ()
271076

  • Fluted surgical drill bit, single-use
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
Z-MED-X 9X2X7X6X100X.035 PDZ405
B BRAUN INTERVENTIONAL SYSTEMS, INC
618405
Not in Commercial Distribution

  • 04046964314155 ()
618405

  • Cardiac valvuloplasty catheter
Z-MED-X 8X6X7X6X100X.035 PDZ404
B BRAUN INTERVENTIONAL SYSTEMS, INC
618404
Not in Commercial Distribution

  • 04046964314131 ()
618404

  • Cardiac valvuloplasty catheter
Z-MED-X 8X5X7X6X100X.035 PDZ403
B BRAUN INTERVENTIONAL SYSTEMS, INC
618403
Not in Commercial Distribution

  • 04046964314117 ()
618403

  • Cardiac valvuloplasty catheter
Z-MED-X 8X4X7X6X100X.035 PDZ402
B BRAUN INTERVENTIONAL SYSTEMS, INC
618402
Not in Commercial Distribution

  • 04046964314094 ()
618402

  • Cardiac valvuloplasty catheter
Z-MED-X 8X3X7X6X100X.035 PDZ401
B BRAUN INTERVENTIONAL SYSTEMS, INC
618401
Not in Commercial Distribution

  • 04046964314070 ()
618401

  • Cardiac valvuloplasty catheter
Z-MED-X 8X2X7X6X100X.035 PDZ400
B BRAUN INTERVENTIONAL SYSTEMS, INC
618400
Not in Commercial Distribution

  • 04046964314056 ()
618400

  • Cardiac valvuloplasty catheter
TYSHAK-X 25X6X11X9X100X.035 PDC347
B BRAUN INTERVENTIONAL SYSTEMS, INC
618347
In Commercial Distribution

  • 04046964314032 ()
618347

  • Cardiac valvuloplasty catheter
TYSHAK-X 25X5X11X9X100X.035 PDC346
B BRAUN INTERVENTIONAL SYSTEMS, INC
618346
In Commercial Distribution

  • 04046964314018 ()
618346

  • Cardiac valvuloplasty catheter
TYSHAK-X 25X4X11X9X100X.035 PDC345
B BRAUN INTERVENTIONAL SYSTEMS, INC
618345
In Commercial Distribution

  • 04046964313998 ()
618345

  • Cardiac valvuloplasty catheter
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