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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TG Ab - CENTAUR - CTL - 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10630917
In Commercial Distribution

  • 00630414587905 ()
10630917

  • Thyroglobulin antibody IVD, control
PAP - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385588
In Commercial Distribution

  • 00630414996639 ()
PACM

  • Prostatic acid phosphatase (PAP) IVD, control
H.Pylori - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469596
In Commercial Distribution

  • 00630414989907 ()
LHPGCM

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control
Salvin TG Driver
SALVIN DENTAL SPECIALTIES, LLC
TG
In Commercial Distribution

  • 00841336111530 ()
TG

  • Dental torque wrench
Toxoplasma IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469600
In Commercial Distribution

  • 00630414976747 ()
LTXPCM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Rubella IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469599
In Commercial Distribution

  • 00630414976730 ()
LRUBCM

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
Rubella IGM - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469597
In Commercial Distribution

  • 00630414976716 ()
LRMCM

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
CMV IgG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469595
In Commercial Distribution

  • 00630414976709 ()
LCVGCM

  • Cytomegalovirus (CMV) antigen IVD, control
Syphillis - IMMULITE - CTL - 2x6mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469593
In Commercial Distribution

  • 00630414976686 ()
LSYCM

  • Treponema pallidum reagin antibody IVD, control
TBG - IMMULITE - CTL - 2x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385244
In Commercial Distribution

  • 00630414953298 ()
LTBCM

  • Thyroxine binding globulin (TBG) IVD, control
Pyrilinks-D - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385243
In Commercial Distribution

  • 00630414953281 ()
LPDCM

  • Collagen pyridium crosslink IVD, control
PTH - IMMULITE - CTL - 6x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385354
In Commercial Distribution

  • 00630414953236 ()
LPHCM

  • Parathyroid hormone (PTH) IVD, control
IGF - IMMULITE - CTL - 2x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385387
In Commercial Distribution

  • 00630414953212 ()
LGCOCM

  • Insulin-like growth factor I (IGF1) IVD, control
HCG - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385358
In Commercial Distribution

  • 00630414953205 ()
LCGCM

  • Total human chorionic gonadotropin IVD, control
Gastrin - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385331
In Commercial Distribution

  • 00630414953199 ()
LGACM

  • Gastrin IVD, control
Albumin - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385388
In Commercial Distribution

  • 00630414953106 ()
LHACM

  • Albumin IVD, control
ACTH - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385382
In Commercial Distribution

  • 00630414953090 ()
LACCM

  • Adrenocorticotropic hormone (ACTH) IVD, control
C-Peptide - IMMULITE - CTL - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385589
In Commercial Distribution

  • 00630414953007 ()
PECM

  • C-peptide IVD, control
B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385587
In Commercial Distribution

  • 00630414952956 ()
BMCM

  • Beta-2-microglobulin IVD, control
Estradiol - IMMULITE - CTL - 1x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10389765
In Commercial Distribution

  • 00630414974095 ()
E2TC1

  • Estradiol (oestradiol) (E2) IVD, control
SHBG - IMMULITE - CTL - 1x1x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10285226
In Commercial Distribution

  • 00630414998947 ()
LSHCM

  • Sex hormone binding globulin (SHBG) IVD, control
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
TOOL
HI-TEC IMPLANTS LTD.
CTL
In Commercial Distribution

  • 07290110723569 ()
CTL

  • Dental implant/prosthesis surgical procedure kit
TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe
INFECTION CTL SYSTEM IR KIT
MEDLINE INDUSTRIES, INC.
DYKC1249
In Commercial Distribution

  • 10889942574063 ()
  • 40889942574064 ()
DYKC1249

  • General surgical procedure kit, non-medicated, single-use
PTH Intact - CENTAUR - CTL - 3x2x2mL
Siemens Healthcare Diagnostics Inc.
10492378
In Commercial Distribution

  • 00630414579184 ()
10492378

  • Parathyroid hormone (PTH) IVD, control
IgE total - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385349
In Commercial Distribution

  • 00630414953458 ()
IECM

  • Total immunoglobulin E (IgE total) IVD, control
Serum Drug - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385397
In Commercial Distribution

  • 00630414953410 ()
SDCM

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Thyroid Autoab - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385381
In Commercial Distribution

  • 00630414953335 ()
LAACM

  • Thyroglobulin IVD, control
Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent
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