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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Contains three vials of each Specific IgE Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgE method.
Phadia AB
10-9408-01
In Commercial Distribution

  • 07333066019604 ()
10-9408-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
Phadia AB
14-6016-01
In Commercial Distribution

  • 07333066017549 ()
14-6016-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
Phadia AB
14-6015-01
In Commercial Distribution

  • 07333066017532 ()
14-6015-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
Phadia AB
14-6014-01
In Commercial Distribution

  • 07333066017525 ()
14-6014-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine
Phadia AB
14-5997-02
In Commercial Distribution

  • 07333066017518 ()
14-5997-02

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e231, Allergen component rFel d 7 Cat
Phadia AB
14-6082-01
In Commercial Distribution

  • 07333066016924 ()
14-6082-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen e230, Allergen component rCan f 6 Dog
Phadia AB
14-6081-01
In Commercial Distribution

  • 07333066016917 ()
14-6081-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen f447, Allergen component rAra h 6 Peanut
Phadia AB
14-6041-01
In Commercial Distribution

  • 07333066016009 ()
14-6041-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen w1, Common ragweed
Phadia AB
14-4531-01
In Commercial Distribution

  • 07333066015903 ()
14-4531-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee
Phadia AB
14-6004-01
In Commercial Distribution

  • 07333066015071 ()
14-6004-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Oxygen Sensor
MAXTEC, LLC
R125P03-002
In Commercial Distribution

  • 00853061006906 ()


  • Respiratory oxygen sensor
No Description
HONSUN (NANTONG) CO.,LTD
LD-737
In Commercial Distribution

  • 01697038425005 ()
  • 11697038425002 ()


  • Automatic-inflation electronic sphygmomanometer, portable, finger
4.0MM 50° ABLATOR
E Surgical, LLC
RB4050-01
In Commercial Distribution

  • 00850053927041 ()
RB4050-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 50° ASPIRATING ABLATOR
E Surgical, LLC
RB4050A-01
In Commercial Distribution

  • 10850053927031 ()
  • 00850053927034 ()
RB4050A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ABLATOR
E Surgical, LLC
RB4090-01
In Commercial Distribution

  • 10850053927024 ()
  • 00850053927027 ()
RB4090-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
4.0MM 90° ASPIRATING ABLATOR
E Surgical, LLC
RB4090A-01
In Commercial Distribution

  • 00850053927010 ()
  • 10850053927017 ()
RB4090A-01

  • Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
E Supreme Cover Size 17
TRULIFE LIMITED
C344 17
In Commercial Distribution

  • 00643293010976 ()


  • External breast prosthesis
E Supreme Cover Size 16
TRULIFE LIMITED
C344 16
In Commercial Distribution

  • 00643293010969 ()


  • External breast prosthesis
E Supreme Cover Size 15
TRULIFE LIMITED
C344 15
In Commercial Distribution

  • 00643293010952 ()


  • External breast prosthesis
E Supreme Cover Size 14
TRULIFE LIMITED
C344 14
In Commercial Distribution

  • 00643293010945 ()


  • External breast prosthesis
E Supreme Cover Size 13
TRULIFE LIMITED
C344 13
In Commercial Distribution

  • 00643293010938 ()


  • External breast prosthesis
E Supreme Cover Size 12
TRULIFE LIMITED
C344 12
In Commercial Distribution

  • 00643293010921 ()


  • External breast prosthesis
E Supreme Cover Size 11
TRULIFE LIMITED
C344 11
In Commercial Distribution

  • 00643293010914 ()


  • External breast prosthesis
E Supreme Cover Size 10
TRULIFE LIMITED
C344 10
In Commercial Distribution

  • 00643293010907 ()


  • External breast prosthesis
E Supreme Cover Size 9
TRULIFE LIMITED
C344 09
In Commercial Distribution

  • 00643293010891 ()


  • External breast prosthesis
E Supreme Cover Size 8
TRULIFE LIMITED
C344 08
In Commercial Distribution

  • 00643293010884 ()


  • External breast prosthesis
E Supreme Cover Size 7
TRULIFE LIMITED
C344 07
In Commercial Distribution

  • 00643293010877 ()


  • External breast prosthesis
E Supreme Cover Size 6
TRULIFE LIMITED
C344 06
In Commercial Distribution

  • 00643293010860 ()


  • External breast prosthesis
E Supreme Cover Size 5
TRULIFE LIMITED
C344 05
In Commercial Distribution

  • 00643293010853 ()


  • External breast prosthesis
E Supreme Cover Size 4
TRULIFE LIMITED
C344 04
In Commercial Distribution

  • 00643293010846 ()


  • External breast prosthesis
E Supreme Cover Size 3
TRULIFE LIMITED
C344 03
In Commercial Distribution

  • 00643293010839 ()


  • External breast prosthesis
E Supreme Cover Size 2
TRULIFE LIMITED
C344 02
In Commercial Distribution

  • 00643293010822 ()


  • External breast prosthesis
E Supreme Cover Size 1
TRULIFE LIMITED
C344 01
In Commercial Distribution

  • 00643293010815 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 17
TRULIFE LIMITED
509 17
In Commercial Distribution

  • 00643293000458 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 16
TRULIFE LIMITED
509 16
In Commercial Distribution

  • 00643293000441 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 15
TRULIFE LIMITED
509 15
In Commercial Distribution

  • 00643293000434 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 14
TRULIFE LIMITED
509 14
In Commercial Distribution

  • 00643293000427 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 13
TRULIFE LIMITED
509 13
In Commercial Distribution

  • 00643293000410 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 12
TRULIFE LIMITED
509 12
In Commercial Distribution

  • 00643293000403 ()


  • External breast prosthesis
E Supreme Breast Protehsis Size 11
TRULIFE LIMITED
509 11
In Commercial Distribution

  • 00643293000397 ()


  • External breast prosthesis
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