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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
CAPTIVA SPINE, INC.
CP30024
In Commercial Distribution

  • M739CP300240 ()


  • Spinal fixation plate, non-bioabsorbable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363246
In Commercial Distribution

  • 09421028118460 ()
287363246

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363244
In Commercial Distribution

  • 09421028118446 ()
287363244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET20224T
In Commercial Distribution

  • 09421028118385 ()
LET20224T

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET30324T
In Commercial Distribution

  • 09421028118361 ()
LET30324T

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax
No Description
BIOTECHNOLOGY INSTITUTE SL
DHG24
In Commercial Distribution

  • 08435389801818 ()


  • Surgical screwdriver, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
DC24
In Commercial Distribution

  • 08435389801795 ()


  • Surgical screwdriver, reusable
No Description
Dynarex Corporation
36277
In Commercial Distribution

  • 00840117323322 ()
  • 00840117315396 ()
  • 00840117315303 ()


  • Nasopharyngeal airway, single-use
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
REDAX SPA
10526
In Commercial Distribution

  • 18034139296606 ()
  • 08034139296609 ()
10526

  • Closed-wound drain connector
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21824
In Commercial Distribution

  • 18034139293780 ()
  • 08034139293783 ()
21824

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20824
In Commercial Distribution

  • 18034139292844 ()
  • 08034139292847 ()
20824

  • Pleural catheter
No Description
Eckert & Ziegler BEBIG GmbH
LAH02-24#03
Not in Commercial Distribution

  • 04049223106621 ()
LAH02-24

  • General-purpose brachytherapy system applicator, remote-afterloading
Neurofeedback headbox
DEYMED Diagnostic s.r.o.
43-139
In Commercial Distribution

  • 08592566431395 ()
43-139

  • Psychophysiological biofeedback system
MRI Coil
Siemens Shenzhen Magnetic Resonance Ltd.
10837354
In Commercial Distribution

  • 04056869015521 ()


  • Full-body MRI system, superconducting magnet
No Description
CELL MARQUE CORPORATION
312M-18
In Commercial Distribution

  • 00841683134985 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-17
In Commercial Distribution

  • 00841683134978 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-16
In Commercial Distribution

  • 00841683134961 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-15
In Commercial Distribution

  • 00841683134954 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
No Description
CELL MARQUE CORPORATION
312M-14
In Commercial Distribution

  • 00841683134916 ()


  • B-cell specific activator protein (BSAP) IVD, antibody
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