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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28 FR Round Fluted, Full
TYPENEX MEDICAL LLC
WD0506
In Commercial Distribution

  • 00812269030588 ()
  • 00812269030571 ()


  • Closed-wound drain, non-bioabsorbable
28 FR Straight – Silicone Catheter
Atrium Medical Corporation
14028
Not in Commercial Distribution

  • 20650862140280 ()

  • Catheter Gauge: 28 French
14028

  • Pleural catheter
COIL APB 2-8 HX-ES V06
Micro Therapeutics, Inc.
APB-2-8-HX-ES
In Commercial Distribution

  • 00763000313906 ()


  • Neurovascular embolization coil
Guidewire 28/40/FC/ST
ARGON MEDICAL DEVICES, INC.
395962
Not in Commercial Distribution

  • 10886333212221 ()
  • 00886333212224 ()
  • 20886333212228 ()

  • .028" x 40cm
395962

  • Peripheral vascular guidewire, manual
Pro Advantage Glutaraldehyde 28 Gallon
NATIONAL DISTRIBUTION & CONTRACTING, INC.
N099002
In Commercial Distribution

  • M220N0990025 ()
  • M220N0990028 ()
N099002

  • Glutaraldehyde device sterilant
NASOPHARYNGEAL AIRWAY SILICONE 28 FR
KENTRON HEALTHCARE, INC.
826428
In Commercial Distribution

  • 00810003754547 ()
  • 00810003754530 ()
  • 00810003754554 ()


  • Nasopharyngeal airway, single-use
Bolus Tube for 28 Fr
Bard Access Systems, Inc.
000269
Not in Commercial Distribution

  • 10801741080873 ()
  • 00801741080876 ()
  • 20801741080870 ()

  • Length: 25.4 Centimeter
  • Catheter Gauge: 28 French
000269

  • Gastrostomy tube
OSSOFF PROBE STRAIGHT 28 CENTIMETER
TELEFLEX INCORPORATED
IPN008144
In Commercial Distribution

  • 24026704533125 ()
  • 04026704533121 ()

  • Length: 330 Millimeter
509304

  • Abdominal/ENT/orthopaedic surgical probe, reusable
JACKSON LARYNGEAL DILATOR 28 FRENCH
TELEFLEX INCORPORATED
IPN007989
In Commercial Distribution

  • 24026704532289 ()
  • 04026704532285 ()

  • Length: 330 Millimeter
507509

  • Oesophageal bougie, reusable
VAN BUREN SOUND 28 FRENCH
TELEFLEX INCORPORATED
IPN004646
In Commercial Distribution

  • 24026704515220 ()
  • 04026704515226 ()

  • Length: 275 Millimeter
241128

  • Urethral sound, reusable
Burn Dressing Vest 28 PLY
DEROYAL INDUSTRIES, INC.
10-5514
In Commercial Distribution

  • 50749756038749 ()
  • 00749756038744 ()
10-5514

  • Wound-nonadherent dressing, permeable, non-antimicrobial
MOL BD MAN RGHT 28
Rmo, Inc.
R00652
In Commercial Distribution

  • 00000008857972 ()
  • 00885797118103 ()


  • Orthodontic metal band
MOL BD MAN LEFT 28
Rmo, Inc.
L00652
In Commercial Distribution

  • 00000008857972 ()
  • 00885797103062 ()


  • Orthodontic metal band
REFLECTION XLPE 35 28 50-52
Smith & Nephew, Inc.
71339950
In Commercial Distribution

  • 00885556020777 ()
71339950

  • Non-constrained polyethylene acetabular liner
Modular Liner Size MH/28
MAXX ORTHOPEDICS, INC.
MO-MLHE-MH/28
In Commercial Distribution

  • 00810008120415 ()


  • Non-constrained polyethylene acetabular liner
Modular Liner Size MF/28
MAXX ORTHOPEDICS, INC.
MO-MLHE-MF/28
In Commercial Distribution

  • 00810008120385 ()


  • Non-constrained polyethylene acetabular liner
Modular Liner Size MD/28
MAXX ORTHOPEDICS, INC.
MO-MLHE-MD/28
In Commercial Distribution

  • 00810008120361 ()


  • Non-constrained polyethylene acetabular liner
Modular Liner Size MB/28
MAXX ORTHOPEDICS, INC.
MO-MLHE-MB/28
In Commercial Distribution

  • 00810008120354 ()


  • Non-constrained polyethylene acetabular liner
6.7 x 28 mm screw
Inion Oy
1
In Commercial Distribution

  • M224SPN55069 ()
SPN-5506

  • Spinal bone screw, bioabsorbable
6.0 x 28 mm screw
Inion Oy
1
In Commercial Distribution

  • M224SPN55029 ()
SPN-5502

  • Spinal bone screw, bioabsorbable
Screwdriver Manual UniGrip 28 mm
Nobel Biocare AB
29149
In Commercial Distribution

  • 07332747009071 ()

  • Length: 28.000 Millimeter
29149

  • Surgical screwdriver, reusable
KFile 28/30 CCC P
TULSA DENTAL PRODUCTS LLC
06328030P
In Commercial Distribution

  • D71606328030P1 ()
06328030P

  • Manual endodontic file/rasp, reusable
KFile 28/25 CCC P
TULSA DENTAL PRODUCTS LLC
06328025P
In Commercial Distribution

  • D71606328025P1 ()
06328025P

  • Manual endodontic file/rasp, reusable
KFile 28/08 CCC P
TULSA DENTAL PRODUCTS LLC
06328008P
In Commercial Distribution

  • D71606328008P1 ()
06328008P

  • Manual endodontic file/rasp, reusable
AAA GUIDE DEVICE 28 EIFU
MEDTRONIC, INC.
HG-16-62-28
In Commercial Distribution

  • 00763000025267 ()

  • Outer Diameter: 5.3 Millimeter
  • Length: 28.0 Millimeter
  • Length: 62.0 Centimeter


  • Soft-tissue/mesh anchor, non-bioabsorbable
AAA GUIDE DEVICE 28 EIFU
MEDTRONIC, INC.
HG-16-62-28
In Commercial Distribution

  • 00763000006631 ()

  • Length: 28.0 Millimeter
  • Outer Diameter: 5.3 Millimeter
  • Length: 62.0 Centimeter


  • Soft-tissue/mesh anchor, non-bioabsorbable
HXLPE MH/28 Modular Liner
MAXX ORTHOPEDICS, INC.
MO-MLHD-MH/28
In Commercial Distribution

  • 00810008120248 ()


  • Metal-on-polyethylene total hip prosthesis
Visual Obturator 27/28 CH
RZ-Medizintechnik GmbH
253-000-087
In Commercial Distribution

  • 04049197393409 ()
253-000-087

  • Resectoscope
Deflecting Obturator 27/28 CH
RZ-Medizintechnik GmbH
253-000-057
In Commercial Distribution

  • 04049197393386 ()
253-000-057

  • Resectoscope
Standard Obturator 27/28 CH
RZ-Medizintechnik GmbH
253-000-047
In Commercial Distribution

  • 04049197177467 ()
253-000-047

  • Resectoscope
InCORPorate VBR Implant 33 W x 28 L x 28 H mm Parallel
SPINAL ELEMENTS
104-1-3328280
In Commercial Distribution

  • 00840916125752 ()


  • Polymeric spinal interbody fusion cage
Bands 1st Molar LR 28: Orthodontic bands 1st Molar Lower Right, size 28
Ortho Pro Dent LLC
B1-LR-28
In Commercial Distribution

  • 00810152820056 ()


  • Orthodontic metal band
Bands 1st Molar LL 28 ; Orthodontic bands 1st Molar Lower Left, Size 28
Ortho Pro Dent LLC
B1-LL-28
In Commercial Distribution

  • 00810152820049 ()


  • Orthodontic metal band
Bands 1st Molar UL 28: Orthodontic bands 1st Molar Upper Left , size 28
Ortho Pro Dent LLC
B1-UL-28
In Commercial Distribution

  • 00810152820025 ()


  • Orthodontic metal band
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
53.120.US
In Commercial Distribution

  • 04250289513401 ()
53.120.US

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
53.100.US
In Commercial Distribution

  • 04250289510394 ()


  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.051.US
Not in Commercial Distribution

  • 04250289510387 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.050.US
In Commercial Distribution

  • 04250289510370 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.101.US
In Commercial Distribution

  • 04250289510363 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.100.US
In Commercial Distribution

  • 04250289510356 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.101.US.Bulk5
In Commercial Distribution

  • 04250289504942 ()
51.101.US.Bulk5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES ANA HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA HEp-2 Test System is intended for use as aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.100.US
In Commercial Distribution

  • 04250289504461 ()
51.100.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US.BULK5
In Commercial Distribution

  • 04250289513562 ()
51.181.US.BULK5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US
In Commercial Distribution

  • 04250289513487 ()
51.181.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. It provides basic nutrients for cell maintenance.
AL.CHI.MI.A. SRL
KER 001-00
In Commercial Distribution

  • 08021118001408 ()
  • 18021118001405 ()

  • Total Volume: 20 Milliliter


  • Corneal storage medium
No Description
BIOGENEX LABORATORIES
AR125-5R
In Commercial Distribution

  • 00810119672964 ()

  • Total Volume: 6 Milliliter
AR125-5R

  • Toxoplasma gondii total antibody IVD, control
No Description
BIOGENEX LABORATORIES
AN449-5M
In Commercial Distribution

  • 00810119672957 ()

  • Total Volume: 6 Milliliter
AN449-5M

  • p504s protein IVD, antibody
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
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