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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
Zimmer, Inc.
5220-80
In Commercial Distribution

  • 00889024187887 ()

  • 24 mm Diameter
  • Length: 75 Millimeter
00-5220-080-00

  • Knee femur stem prosthesis
No Description
Zimmer, Inc.
5125-11-24
In Commercial Distribution

  • 00889024186989 ()

  • 24 mm Diameter
00-5125-011-24

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Neo Delta Self Safe T
DELTA MED SPA
3718522
In Commercial Distribution

  • 58032248371854 ()
  • 38032248371850 ()
  • 08032248371859 ()

  • Length: 19 Millimeter
  • Gauge 24 G
  • Outer Diameter: 0.74 Millimeter


  • Peripheral vascular catheter
Neo Delta Self Safe 1
DELTA MED SPA
3718122
In Commercial Distribution

  • 58032248371816 ()
  • 38032248371812 ()
  • 08032248371811 ()

  • Gauge 24 G
  • Outer Diameter: 0.74 Millimeter
  • Length: 19 Millimeter


  • Peripheral vascular catheter
Robinson/Nelaton Catheter
CONVATEC, PURCHASING DEPARTMENT
503429
Not in Commercial Distribution

  • 30768455145929 ()
  • 50768455145923 ()
  • 70768455145927 ()

  • 24 FR 40cm
503429

  • Single-administration urethral drainage catheter
Symmetry® Mirror, Laryngeal, Stationary Octagonal Handle, #6 24 mm
SYMMETRY SURGICAL INC.
73-4824
In Commercial Distribution

  • 00887482041338 ()

  • 24 mm Diameter
73-4824

  • Laryngeal mirror, reusable
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm STRATA 300 Size S3T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U3KILTBLOCKERSET
In Commercial Distribution

  • 00840331295290 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm STRATA 300 Size S3T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S3KILTBLOCKERSET
In Commercial Distribution

  • 00840331295221 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm STRATA 300 Size S3T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R3KILTBLOCKERSET
In Commercial Distribution

  • 00840331295153 ()


  • Radiation shielding apron
No Description
OSADA ELECTRIC CO.,LTD.
SRH
In Commercial Distribution

  • 04582227341457 ()
50063

  • Surgical power tool system handpiece, sawing, line-powered
  • Line-powered dental drilling/sawing system handpiece
  • Dental power tool system handpiece, remotely-driven
  • Sawing power tool attachment, reciprocating
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-009-001
Not in Commercial Distribution

  • 00858092006864 ()
00-284-009-001

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
01-389-109-000VK
In Commercial Distribution

  • 00858092006772 ()
01-389-109-000VK

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
01-389-109-000K
In Commercial Distribution

  • 00858092006765 ()
01-389-109-000K

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-389-129-001K
In Commercial Distribution

  • 00858092006758 ()
00-389-129-001K

  • General-purpose centrifuge IVD
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-389-129-000K
In Commercial Distribution

  • 00858092006741 ()
00-389-129-000K

  • General-purpose centrifuge IVD
No Description
ALIMED, INC.
8502
In Commercial Distribution

  • 00733657224382 ()
2970011228

  • Patient transfer sliding board
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
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650-A
In Commercial Distribution

  • 04050674077675 ()
1650-A

  • Microhaematocrit centrifuge IVD
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1650
In Commercial Distribution

  • 04050674030441 ()
1650

  • Microhaematocrit centrifuge IVD
Hematocrit rotor, 24-place
Andreas Hettich GmbH & Co. KG
1023
In Commercial Distribution

  • 04050674030427 ()
1023

  • Microhaematocrit centrifuge IVD
No Description
RPI
LSW002
In Commercial Distribution

  • 00841034114727 ()
LSW002

  • Electrocardiographic lead set, reusable
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