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
TOOL
HI-TEC IMPLANTS LTD.
CTL
In Commercial Distribution

  • 07290110723569 ()
CTL

  • Dental implant/prosthesis surgical procedure kit
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
SHBG - IMMULITE - CTL - 1x1x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10285226
In Commercial Distribution

  • 00630414998947 ()
LSHCM

  • Sex hormone binding globulin (SHBG) IVD, control
Estradiol - IMMULITE - CTL - 1x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10389765
In Commercial Distribution

  • 00630414974095 ()
E2TC1

  • Estradiol (oestradiol) (E2) 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
TG RATCHET ADAPTER
BIOMET 3I, LLC
MDR10H
Not in Commercial Distribution

  • 00844868010098 ()


  • Surgical screwdriver, reusable
TG
Zoll-Dental
PC-TG
In Commercial Distribution

  • 00840105209829 ()


  • Periodontal hoe
Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent
INFECTION CTL SYSTEM IR KIT
MEDLINE INDUSTRIES, INC.
DYKC1249
In Commercial Distribution

  • 10889942574063 ()
  • 40889942574064 ()
DYKC1249

  • General surgical procedure kit, non-medicated, single-use
3.0T HD 8CH CTL ARRAY
USA INSTRUMENTS, INC.
3.0T HD 8CH CTL ARRAY
In Commercial Distribution

  • 00840682104487 ()
2415542

  • MRI system coil, radio-frequency
Insulin Module - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10286614
In Commercial Distribution

  • 00630414998954 ()
LINCM

  • Insulin IVD, control
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
CTL Amedica Navigation Instrument Case
CTL Medical Corporation
109.8701
In Commercial Distribution

  • 00841732143630 ()


  • General internal orthopaedic fixation system implantation kit
Specific IgE Neg - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485107
In Commercial Distribution

  • 00630414984599 ()
L2SNCCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE M6 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485106
In Commercial Distribution

  • 00630414984582 ()
MC6LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
MTS DR. SCHWARTZ KIT-MED CTR CTL GA
MEDLINE INDUSTRIES, INC.
60130797
In Commercial Distribution

  • 20193489046547 ()
  • 10193489046540 ()
60130797

  • Angiography kit
aCCP Control Set - CENTAUR - - CENTAUR - CTL - 1x2x7mL
Siemens Healthcare Diagnostics Inc.
10699150
In Commercial Distribution

  • 00630414592329 ()
10699150

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control
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