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
BIOGENEX LABORATORIES
AM054-5M
In Commercial Distribution

  • 00810119672933 ()

  • Total Volume: 6 Milliliter
AM054-5M

  • Tumour-associated glycoprotein-72 (TAG72) IVD, antibody
No Description
BIOGENEX LABORATORIES
AM947-5M
In Commercial Distribution

  • 00810119672919 ()

  • Total Volume: 6 Milliliter
AM947-5M

  • CD20 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM109-5M
In Commercial Distribution

  • 00810119672896 ()

  • Total Volume: 6 Milliliter
AM109-5M

  • Smooth muscle myosin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM534-5M
In Commercial Distribution

  • 00810119672889 ()

  • Total Volume: 6 Milliliter
AM534-5M

  • Mucin IVD, antibody
No Description
BIOGENEX LABORATORIES
AMA77-5M
In Commercial Distribution

  • 00810119672438 ()

  • Total Volume: 6 Milliliter
AMA77-5M

  • Desmoglein 3 (DSG3) IVD, antibody
No Description
BIOGENEX LABORATORIES
AN783-5M
In Commercial Distribution

  • 00810119672414 ()

  • Total Volume: 6 Milliliter
AN783-5M

  • Glial fibrillary acidic protein (GFAP) IVD, antibody
No Description
BIOGENEX LABORATORIES
AM941-5M
In Commercial Distribution

  • 00810119672407 ()

  • Total Volume: 6 Milliliter
AM941-5M

  • CD45 leukocyte common antigen cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM075-5M
In Commercial Distribution

  • 00810119672391 ()

  • Total Volume: 6 Milliliter
AM075-5M

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM154-5M
In Commercial Distribution

  • 00810119672384 ()

  • Total Volume: 6 Milliliter
AM154-5M

  • HLA-DR antigen tissue typing IVD, antibody
No Description
BIOGENEX LABORATORIES
AM146-5M
In Commercial Distribution

  • 00810119672377 ()

  • Total Volume: 6 Milliliter
AM146-5M

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
AMC16-5M
In Commercial Distribution

  • 00810119672353 ()

  • Total Volume: 6 Milliliter
AMC16-5M

  • Epithelial cell adhesion molecule (EpCAM) IVD, antibody
No Description
BIOGENEX LABORATORIES
AM433-5M
In Commercial Distribution

  • 00810119671653 ()

  • Total Volume: 6 Milliliter
AM433-5M

  • Mesothelin IVD, antibody
No Description
BIOGENEX LABORATORIES
AN743-5M
In Commercial Distribution

  • 00810119671646 ()

  • Total Volume: 6 Milliliter
AN743-5M

  • MSH2 antigen IVD, antibody
No Description
BIOGENEX LABORATORIES
AN740-5M
In Commercial Distribution

  • 00810119671639 ()

  • Total Volume: 6 Milliliter
AN740-5M

  • CD8 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM953-5M
In Commercial Distribution

  • 00810119671622 ()

  • Total Volume: 6 Milliliter
AM953-5M

  • Gross cystic disease fluid protein-15 IVD, antibody
No Description
BIOGENEX LABORATORIES
AN714-5M
In Commercial Distribution

  • 00810119672940 ()

  • Total Volume: 6 Milliliter
AN714-5M

  • Prostate-specific membrane antigen (PSMA) IVD, antibody
No Description
BIOGENEX LABORATORIES
AN769-5M
In Commercial Distribution

  • 00810119671608 ()

  • Total Volume: 6 Milliliter
AN769-5M

  • CD38 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AN921-5M
In Commercial Distribution

  • 00810119670755 ()

  • Total Volume: 6 Milliliter
AN921-5M

  • Programmed death-ligand 1 (PD-L1) IVD, antibody
No Description
Biomet Orthopedics, LLC
31-423708
In Commercial Distribution

  • 00887868268663 ()

  • 28 mm Size 28
31-423708

  • Acetabulum prosthesis trial, prefabricated, reusable
POLARCUP PE INSERT 59/28 NON-CEMENTED
Smith & Nephew, Inc.
75017226
In Commercial Distribution

  • 07611996096514 ()
75017226

  • Non-constrained polyethylene acetabular liner
CANN CB91228C MC2 28/36FR 17L
MEDTRONIC, INC.
CB91228C
In Commercial Distribution

  • 00643169696839 ()

  • 28-36 FR


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
CANN CB91228 MC2 28/36FR 17L
MEDTRONIC, INC.
CB91228
In Commercial Distribution

  • 00643169696822 ()

  • 28-36 FR


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
LATEX FREE ADJ NASO SZ 28
SUNMED, LLC
1-5072-28
In Commercial Distribution

  • 10889483001318 ()

  • Length: 150 Millimeter
1-5072-28

  • Nasopharyngeal airway, single-use
CANN CB91228C MC2 28/36FR 17L
MEDTRONIC, INC.
CB91228C
Not in Commercial Distribution

  • 00643169159525 ()

  • 28-36 FR


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
CANN CB91228 MC2 28/36FR 17L
MEDTRONIC, INC.
CB91228
Not in Commercial Distribution

  • 00643169159518 ()

  • 28-36 FR


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Plate, 1 Level Size 28 mm
K2M, INC.
AA01-41F28V
In Commercial Distribution

  • 10888857401372 ()

  • Length: 28 Millimeter
AA01-41F28V

  • Spinal fixation plate, non-bioabsorbable
Plate, 1 Level Size 28 mm
K2M, INC.
8801-41F28G
In Commercial Distribution

  • 10888857399266 ()

  • Length: 28 Millimeter
8801-41F28G

  • Spinal fixation plate, non-bioabsorbable
Stop tubes, slotted, 22 x 28
DENTAURUM GmbH & Co.KG
480-618-01
In Commercial Distribution

  • J011480618010 ()
  • J011480618011 ()


  • Orthodontic tube
Plate, 1 Level, Size 28 mm
K2M, INC.
8801-41F28
Not in Commercial Distribution

  • 10888857360242 ()

  • Length: 28 Millimeter
8801-41F28

  • Bone-screw internal spinal fixation system, non-sterile
Plate, 1 Level Size 28 mm
K2M, INC.
AA01-41F28V-G1
In Commercial Distribution

  • 10888857416215 ()

  • 1 Level
  • Length: 28 Millimeter
AA01-41F28V-G1

  • Spinal fixation plate, non-bioabsorbable
Plate, 1 Level Size 28 mm
K2M, INC.
8801-41F28G-G1
In Commercial Distribution

  • 10888857405707 ()

  • Length: 28 Millimeter
  • 1 Level
8801-41F28G-G1

  • Spinal fixation plate, non-bioabsorbable
DTS 3032028 ZEVO DISTAL 28 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
3032028
In Commercial Distribution

  • 00643169342385 ()


  • Surgical drill guide, reusable
Lateral Plate, 1 Level Size 28
K2M, INC.
4508-41F28
In Commercial Distribution

  • 10888857094543 ()

  • Length: 28 Millimeter
4508-41F28

  • Spinal fixation plate, non-bioabsorbable
28" DETACHABLE RAIL 9.4MM X 28.5MM
TIDI PRODUCTS, LLC
9430
Not in Commercial Distribution

  • 00618125183593 ()


  • Instrument table
6.0 x 28 LUMBAR SCREW ASSEMBLY
Pioneer Surgical Technology, Inc.
25-60-28
Not in Commercial Distribution

  • 00846468028466 ()
25-60-28

  • Spinal fixation plate, non-bioabsorbable
6.5 x 28 RESCUE SCREW ASSEMBLY
Pioneer Surgical Technology, Inc.
25-65-28
Not in Commercial Distribution

  • 00846468028565 ()
25-65-28

  • Spinal fixation plate, non-bioabsorbable
OS Cas, Yellow, 28 LP Rails
HU-FRIEDY MFG. CO., LLC
IMOS285LP
In Commercial Distribution

  • 10889950141226 ()


  • Device sterilization/disinfection container, reusable
Thoraguard Chest Tube Kit, 28 Fr
CENTESE, INC.
FGS-2000
In Commercial Distribution

  • 00860000436441 ()

  • Catheter Gauge: 28 French
TGCT120028

  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
  • Sump drain
#28/29 BURNISHER DE, SATIN STEEL
HU-FRIEDY MFG. CO., LLC
BB43626
Not in Commercial Distribution

  • 10889950041830 ()
BB43626

  • Manual dental burnisher, reusable
#28 DE Margin Trimmer (10-95-7-14) #9Hdl
HU-FRIEDY MFG. CO., LLC
MT289
In Commercial Distribution

  • 10889950015862 ()
MT289

  • Margin finishing dental file/rasp, reusable
#28 DE Margin Trimmer, Satin Steel
HU-FRIEDY MFG. CO., LLC
MT286
In Commercial Distribution

  • 10889950015855 ()
MT286

  • Margin finishing dental file/rasp, reusable
TURBINE ASSY, 28" DEEP TANK, 220V
Whitehall Manufacturing Co
TA-28-S-220V
In Commercial Distribution

  • 00645724004424 ()
TA28S220V

  • Hydro-massage turbine
TURBINE ASSY, 28" DEEP TANK, 220V
Whitehall Manufacturing Co
TA-28-M-220V
In Commercial Distribution

  • 00645724004417 ()
TA28M220V

  • Hydro-massage turbine
TRULIFE SACH WITH PYRAMID 28 R
TRULIFE LIMITED
0800502
In Commercial Distribution

  • 00645517865997 ()


  • Ankle/foot orthosis
TRULIFE SACH WITH PYRAMID 28 L
TRULIFE LIMITED
SCH110-28L
In Commercial Distribution

  • 00645517865980 ()


  • Mechanical-resistance external ankle-foot prosthesis
FOOT KINETIC LIGHT RT 28 #5
TRULIFE LIMITED
SKF100-28-R-5B8
In Commercial Distribution

  • 00645517839851 ()


  • Mechanical-resistance external ankle-foot prosthesis
FOOT KINETIC LIGHT RT 28 #4
TRULIFE LIMITED
SKF100-28-R-4B8
In Commercial Distribution

  • 00645517839844 ()


  • Mechanical-resistance external ankle-foot prosthesis
FOOT KINETIC LIGHT RT 28 #3
TRULIFE LIMITED
SKF100-28-R-3B8
In Commercial Distribution

  • 00645517839837 ()


  • Mechanical-resistance external ankle-foot prosthesis
FOOT KINETIC LIGHT RT 28 #2
TRULIFE LIMITED
SKF100-28-R-2A8
In Commercial Distribution

  • 00645517839820 ()


  • Mechanical-resistance external ankle-foot prosthesis
FOOT KINETIC LIGHT LFT 28 #5
TRULIFE LIMITED
SKF100-28-L-5B8
In Commercial Distribution

  • 00645517839806 ()


  • Mechanical-resistance external ankle-foot prosthesis
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