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
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-160
In Commercial Distribution

  • 09348215056575 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-102-080
In Commercial Distribution

  • 09348215056377 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-28-0097
In Commercial Distribution

  • 09348215051280 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
WAXING INSTRUMENT #5 GRAY
HAGER WORLDWIDE, INC.
304055
Not in Commercial Distribution

  • D24830405510 ()


  • Dental restoration carver, multiple-material
WAXING INSTRUMENT #5 GRAY
HAGER WORLDWIDE, INC.
304055
In Commercial Distribution

  • D2483040550 ()


  • Dental restoration carver, multiple-material
Chrome-plated air/water syringe
HAGER WORLDWIDE, INC.
BOA124P1000
In Commercial Distribution

  • D248B16280 ()
  • D248BOA124P10001 ()


  • Dental delivery system irrigation handpiece tip
Wire Clip-On Loupe (+5) Eyewear
HAGER WORLDWIDE, INC.
87048
In Commercial Distribution

  • D2488704809 ()


  • Eye splash shield, reusable
Spring Clip-On Loupe (+5) Eyewear
HAGER WORLDWIDE, INC.
87023
In Commercial Distribution

  • D2488702302 ()


  • Eye splash shield, reusable
No Description
DATASCOPE CORP.
T 50002
Not in Commercial Distribution

  • 00607567208568 ()
709000235

  • Cardiopulmonary bypass system blood tubing set
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
351
In Commercial Distribution

  • 00842430111693 ()
351

  • Traction weight
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5875-05
In Commercial Distribution

  • 00842430110252 ()
5875-05

  • Operating table torso positioner
Conformity stem, collared, #5
UNITED ORTHOPEDIC CORP.
1110-1005
In Commercial Distribution

  • 04711605582988 ()
1110-1005

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
2410C 5W STCK.625 1.375/1.125
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009572 ()
112669

  • Pulmonary function valve
2410B 5W STCK.625FB 1.125/22MM
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009565 ()
112668

  • Pulmonary function valve
2410A 5W STPCK.625FB 22MM/.75
HANS RUDOLPH, INC.
2410
Not in Commercial Distribution

  • 00874750009558 ()
112667

  • Pulmonary function valve
2420C 5W STPCK 22/15MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009541 ()
112666

  • Pulmonary function valve
2420B 5W STPCK 15/10.5MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009534 ()
112665

  • Pulmonary function valve
2420A 5W STPCK 10.5/7.5MM
HANS RUDOLPH, INC.
2420
Not in Commercial Distribution

  • 00874750009527 ()
112664

  • Pulmonary function valve
2460C 5W STCK.187FB 15/10.5MM
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009510 ()
112663

  • Pulmonary function valve
2460B 5W STCK.187FB 10.5/7.5MM
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009503 ()
112662

  • Pulmonary function valve
2460A 5W STCK.187FB 7.5MM/.187
HANS RUDOLPH, INC.
2460
Not in Commercial Distribution

  • 00874750009497 ()
112661

  • Pulmonary function valve
2400C 5WAY STPCK 1.375ODPORTS"
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008384 ()
112256

  • Pulmonary function valve
2400B 5 WAY STPCK 1.125ODPORTS
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008377 ()
112255

  • Pulmonary function valve
2400A 5W STPCK 22MM/.75 PORTS
HANS RUDOLPH, INC.
2400
Not in Commercial Distribution

  • 00874750008360 ()
112254

  • Pulmonary function valve
No Description
Drägerwerk AG & Co. KGaA
MP03885
In Commercial Distribution

  • 04048675419341 ()
  • 04048675378563 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03884
In Commercial Distribution

  • 04048675419334 ()
  • 04048675378556 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03883
In Commercial Distribution

  • 04048675419327 ()
  • 04048675378549 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03882
In Commercial Distribution

  • 04048675419310 ()
  • 04048675378532 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03881
In Commercial Distribution

  • 04048675419303 ()
  • 04048675378525 ()


  • Nasal oxygen cannula, CPAP
No Description
Drägerwerk AG & Co. KGaA
MP03880
In Commercial Distribution

  • 04048675418993 ()
  • 04048675378518 ()


  • Nasal oxygen cannula, CPAP
Content: 1 piece Height: 14 mm
ZIRKONZAHN SRL
ZRSF8021
In Commercial Distribution

  • D800ZRSF8021 ()


  • Dental appliance fabrication material, ceramic
Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns and small bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0301
In Commercial Distribution

  • D800ZRAD0301 ()


  • Dental bridge, ceramic
No Description
BIOMET MICROFIXATION, INC
91-6604-5PK
Not in Commercial Distribution

  • 00841036138233 ()
91-6604-5PK

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
5BD acrylic baseplate
MEDTEC, INC.
105021
In Commercial Distribution

  • 00841439100189 ()
105021

  • Patient positioner base plate
No Description
Roche Diagnostics GmbH
05915686190
In Commercial Distribution

  • 04015630946594 ()
05915686190

  • Procalcitonin (PCT) IVD, control
No Description
Roche Diagnostics GmbH
5918103160
In Commercial Distribution

  • 04015630927999 ()
5918103160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5918065160
In Commercial Distribution

  • 04015630927951 ()
5918065160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5918022160
In Commercial Distribution

  • 04015630927937 ()
5918022160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5918014160
In Commercial Distribution

  • 04015630927920 ()
5918014160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917999160
In Commercial Distribution

  • 04015630927913 ()
5917999160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917913160
In Commercial Distribution

  • 04015630927883 ()
5917913160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917891160
In Commercial Distribution

  • 04015630927869 ()
5917891160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917883160
In Commercial Distribution

  • 04015630927852 ()
5917883160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917875160
In Commercial Distribution

  • 04015630927845 ()
5917875160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5917794160
In Commercial Distribution

  • 04015630927784 ()
5917794160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
6445888160
In Commercial Distribution

  • 04015630933419 ()
6445888160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
6347142160
In Commercial Distribution

  • 04015630930487 ()
6347142160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
6270069160
In Commercial Distribution

  • 04015630930081 ()
6270069160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
5942357160
In Commercial Distribution

  • 04015630930074 ()
5942357160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
Roche Diagnostics GmbH
6269915160
In Commercial Distribution

  • 04015630930050 ()
6269915160

  • Multiple-type clinical chemistry analyte profile IVD, control
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