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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
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130211007M
In Commercial Distribution

  • 06947145578053 ()
130211007M

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130202022M
In Commercial Distribution

  • 06947145578046 ()
130202022M

  • Total human chorionic gonadotropin IVD, control
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130602022M
In Commercial Distribution

  • 06947145578039 ()
130602022M

  • Total human chorionic gonadotropin IVD, control
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130203016M
In Commercial Distribution

  • 06947145577988 ()
130203016M

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130603016M
In Commercial Distribution

  • 06947145577971 ()
130603016M

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130603013M
In Commercial Distribution

  • 06947145500023 ()
130603013M

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130203013M
In Commercial Distribution

  • 06947145500016 ()
130203013M

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution

  • 00840763100384 ()


  • Mechanical skin contouring system motor
Neonatal Single-Patient Size #4, Circ: 7.1 - 13.1 cm, incorporates the new connector configuration, replaces the M1872A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #4
Not in Commercial Distribution

  • 20884838008551 ()
  • 00884838008557 ()

  • Circumference: 13.1 Centimeter
M1872B

  • Blood pressure cuff, reusable
Neonatal Single-Patient Size #3, Circ: 5.8 - 10.9 cm, incorporates the new connector configuration, replaces the M1870A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #3
Not in Commercial Distribution

  • 20884838008537 ()
  • 00884838008533 ()

  • Circumference: 10.9 Centimeter
M1870B

  • Blood pressure cuff, reusable
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