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
DIO Corporation
ST 06BL
In Commercial Distribution

  • 08800049204627 ()


  • Dental instrument depth limiter
No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent
IgM (Immunoglobulin M) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC638
Not in Commercial Distribution

  • 00817302020953 ()

  • Total Volume: 8 Milliliter
  • Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
  • Total Volume: 23 Milliliter
CC638

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-015
In Commercial Distribution

  • 00816426020115 ()
KAI-015

  • Total immunoglobulin M (IgM total) IVD, reagent
For the quantitative determination of human IgA in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-013
In Commercial Distribution

  • 00816426020092 ()
KAI-013

  • Total immunoglobulin A (IgA total) IVD, reagent
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761160 ()
116002

  • Total immunoglobulin G (IgG total) IVD, control
JBAIDS IVD Influenza A/H5 Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0136
Not in Commercial Distribution

  • 00851458005082 ()
JRPD-ASY-0136

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
5mm 45cm Atraumatic, Endo-Clinch Grasper, Wtih On/Off Style Ratchet Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13238-13
In Commercial Distribution

  • B382SD13238130 ()
SD13238-13

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 32cm Hunter Bowel Grasper, Fenestrated, 22mm Jaw, With Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD15718-25
In Commercial Distribution

  • B382SD15718250 ()
SD15718-25

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 36cm Atraumatic, Long Jaw, Wave Grasper, Single Action Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13818-21
In Commercial Distribution

  • B382SD13818210 ()
SD13818-21

  • Flexible endoscopic tissue manipulation forceps, single-use
5mm 32cm Johan Grasper, 22mm Single Action Jaws, Rotating, Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13128-25
In Commercial Distribution

  • B382SD13128250 ()
SD13128-25

  • Flexible endoscopic tissue manipulation forceps, single-use
No Description
THE BINDING SITE GROUP LIMITED
NK623.T.A
In Commercial Distribution

  • 05051700016919 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system
No Description
Liceguard, LLC
Egg & Lice Combing Kit
In Commercial Distribution

  • 00663580009209 ()


  • Lice removal/prevention kit
No Description
Liceguard, LLC
No Nit Kit
In Commercial Distribution

  • 00663580000800 ()


  • Lice removal/prevention kit
LUMINELLE Aspirator
UVISION 360, INC.
LUM-A
In Commercial Distribution

  • 10853277008104 ()
  • 00853277008107 ()
20081

  • Endocervical aspirator
Disposable Biopsy Valve, for Olympus and Fujinon GI Endoscopes, single use, non sterile, latex free, 10/pk
BR Surgical, LLC
BR981-26050
In Commercial Distribution

  • 00840183515317 ()
BR981-26050

  • Endoscope working-channel valve, single-use
HPLC Basic Kit, Vitamins A and E in serum/plasma, with 96 Deep Well Plates
Chromsystems Instruments + Chemicals GmbH
34400-DWP-BK
In Commercial Distribution

  • 04250317554789 ()

  • 200 analyses
34400-DWP-BK

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, Vitamins A and E in serum/plasma, with 96 Deep Well Plates
Chromsystems Instruments + Chemicals GmbH
34400-DWP
In Commercial Distribution

  • 04250317554772 ()

  • 200 analyses
34400-DWP

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Basic Kit, Vitamins A and E in serum/plasma with Reaction Vials
Chromsystems Instruments + Chemicals GmbH
34400-BK
In Commercial Distribution

  • 04250317554765 ()

  • 200 analyses
34400-BK

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34400
In Commercial Distribution

  • 04250317554758 ()

  • 200 analyses
34400

  • Multiple vitamin IVD, kit, liquid chromatography
Cross-slitted Adhesive Seals for 96 well plates, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34459
In Commercial Distribution

  • 04250317553447 ()

  • 3 pcs.
34459

  • Microplate IVD
96 Deep Well Plates, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34456
In Commercial Distribution

  • 04250317553430 ()

  • 6 pcs.
34456

  • Microplate IVD
Internal Standard, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34404
In Commercial Distribution

  • 04250317552884 ()

  • 40 ml
34404

  • Multiple vitamin IVD, reagent
Precipitation Reagent, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34405
In Commercial Distribution

  • 04250317552877 ()

  • 40 ml
34405

  • Multiple vitamin IVD, reagent
UHPLC Reagent Kit, One Step Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34934/UHPLC
In Commercial Distribution

  • 04250317550712 ()

  • 1000 analyses
34934/UHPLC

  • Multiple vitamin IVD, kit, liquid chromatography
Pre-mixed Solution
Chromsystems Instruments + Chemicals GmbH
34966
In Commercial Distribution

  • 04250317550705 ()

  • 20 ml
34966

  • Multiple vitamin IVD, reagent
HPLC Reagent Kit, One Step Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34034/Premix
In Commercial Distribution

  • 04250317550699 ()

  • 100 analyses
34034/Premix

  • Multiple vitamin IVD, kit, liquid chromatography
Pierceable Heat Seals for 96 Well Plates Vitamins A and E in serum/plasma, Automated with 96 well filter plates
Chromsystems Instruments + Chemicals GmbH
34760
In Commercial Distribution

  • 04250317537058 ()

  • 6 pcs.
34760

  • Microplate IVD
HPLC Reagent Kit, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34700/F
In Commercial Distribution

  • 04250317532770 ()

  • 5 x 96 analyses
34700/F

  • Multiple vitamin IVD, kit, liquid chromatography
UHPLC Reagent Kit, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34900/F
In Commercial Distribution

  • 04250317532749 ()

  • 10 x 96 analyses
34900/F

  • Multiple vitamin IVD, kit, liquid chromatography
HPLC Reagent Kit, One Step Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34000/PREMIX
In Commercial Distribution

  • 04250317532671 ()

  • 100 analyses
34000/PREMIX

  • Multiple vitamin IVD, kit, liquid chromatography
UHPLC One Step Reagent Kit, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34900/UHPLC
In Commercial Distribution

  • 04250317532046 ()

  • 1000 analyses
34900/UHPLC

  • Multiple vitamin IVD, kit, liquid chromatography
96 Well Collection Plates for automated sample preparation, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34758
In Commercial Distribution

  • 04250317526847 ()

  • 5 pcs.
34758

  • Microplate IVD
96 Well Filter Plates for automated sample preparation, Vitamins A and E in serum/plasma
Chromsystems Instruments + Chemicals GmbH
34757
In Commercial Distribution

  • 04250317526830 ()

  • 5 pcs.
34757

  • Microplate IVD
Internal Standard, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
Chromsystems Instruments + Chemicals GmbH
34708
In Commercial Distribution

  • 04250317526823 ()

  • 100 ml
34708

  • Multiple vitamin IVD, reagent
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