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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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Testoterone II (TSTII) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995708
In Commercial Distribution

  • 00630414600222 ()
10995708

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995707
In Commercial Distribution

  • 00630414600215 ()
10995707

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH3-UL Atellica IM - Master Curve Material Kit 10 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995705
In Commercial Distribution

  • 00630414600185 ()
10995705

  • Thyroid stimulating hormone (TSH) IVD, control
TSH3-UL Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
10995704
In Commercial Distribution

  • 00630414600178 ()
10995704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH3-UL Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995703
In Commercial Distribution

  • 00630414600161 ()
10995703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
T3/T4/VB12 Ancillary Reagent Atellica IM - CAL (6PK) 6 x 25mL
Siemens Healthcare Diagnostics Inc.
10995683
In Commercial Distribution

  • 00630414599960 ()
  • 00630414007793 ()
10995683

  • Multiple thyroid marker IVD, reagent
T3/T4/VB12 Ancillary Reagent Atellica IM – CAL (2PK) 2 x 25mL
Siemens Healthcare Diagnostics Inc.
10995682
In Commercial Distribution

  • 00630414599953 ()
  • 00630414007779 ()
10995682

  • Multiple thyroid marker IVD, reagent
A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back.
SMITH & NEPHEW MEDICAL LIMITED
66803060
In Commercial Distribution

  • 05000223497446 ()
  • 05000223497439 ()
  • 05000223497453 ()
66803060

  • Wearable multiple physiological parameter recorder, reusable
RENASYS TOUCH Class I Power Supply
SMITH & NEPHEW MEDICAL LIMITED
66801285
In Commercial Distribution

  • 05000223495527 ()
  • 05000223495510 ()
66801285

  • Basic power supply, reusable
A powered suction pump with accessory Wound Dressing Kits designed for Negative Pressure Wound Therapy (NPWT).
SMITH & NEPHEW MEDICAL LIMITED
66801281
In Commercial Distribution

  • 05000223494476 ()
66801281

  • Basic power supply, reusable
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