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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Rapid Response 2 Parameter Urinalysis Reagent Strips (Glu/Pro) - 100 tests/ kit are for the qualitative or semi-quantitative detection of Glucose and Protein in urine.
BTNX Inc
U2.1-1S100
In Commercial Distribution

  • 00722066000342 ()
  • 00722066003732 ()
U2.1-1S100

  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine.
BTNX Inc
U-KET-1S100
In Commercial Distribution

  • 00722066000335 ()
  • 00722066003725 ()
U-KET-1S100

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma.
BTNX Inc
MON-13C15
In Commercial Distribution

  • 00722066000311 ()
  • 00722066004272 ()
MON-13C15

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine.
BTNX Inc
HCG-1C25
In Commercial Distribution

  • 00722066000274 ()
  • 00722066004166 ()
HCG-1C25

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum,
BTNX Inc
HCG-3C25
In Commercial Distribution

  • 00722066000267 ()
  • 00722066004203 ()
HCG-3C25

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine.
BTNX Inc
HCG-1C50
In Commercial Distribution

  • 00722066000229 ()
  • 00722066004173 ()
HCG-1C50

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of Human Chlorionic Gonadotropin in urine/ serum.
BTNX Inc
HCG-3C50
In Commercial Distribution

  • 00722066000205 ()
  • 00722066004210 ()
HCG-3C50

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens.
BTNX Inc
STR-15S25
In Commercial Distribution

  • 00722066000014 ()
  • 00722066004234 ()
STR-15S25

  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
HEX DRIVER X1103002 WITH AO CHUCK 2.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X1103002
In Commercial Distribution

  • 00721902999093 ()


  • Orthopaedic implant driver
RATCHET HANDLE WITH AO CHUCK
MEDTRONIC SOFAMOR DANEK, INC.
X1103001
In Commercial Distribution

  • 00721902999062 ()


  • Surgical instrument handle, non-torque-limiting
SQUARE DRIVE SHAFT 2.5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
X1003022
In Commercial Distribution

  • 00721902999000 ()


  • Surgical screwdriver, reusable
MINI TORQUE LIMITING HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1003021
In Commercial Distribution

  • 00721902998997 ()


  • Surgical instrument handle, non-torque-limiting
CASE 7055340 CDHL HOOK OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
7055340
In Commercial Distribution

  • 00721902998546 ()


  • Instrument tray, reusable
CASE 7055335 CDHL INS OUTER CASE 2
MEDTRONIC SOFAMOR DANEK, INC.
7055335
In Commercial Distribution

  • 00721902998539 ()


  • Instrument tray, reusable
CASE 7050355L CDHL CLRD II MOD GNRL LID
MEDTRONIC SOFAMOR DANEK, INC.
7050355L
In Commercial Distribution

  • 00721902998096 ()


  • Instrument tray, reusable
INSTRUMENT 6971488 RAIL PUNCH 8MMX18MM
MEDTRONIC SOFAMOR DANEK, INC.
6971488
In Commercial Distribution

  • 00721902998089 ()

  • 6mm x 12mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971487 RAIL PUNCH 7MMX18MM
MEDTRONIC SOFAMOR DANEK, INC.
6971487
In Commercial Distribution

  • 00721902998072 ()

  • 7mm x 18mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971468 RAIL PUNCH 8MMX16MM
MEDTRONIC SOFAMOR DANEK, INC.
6971468
In Commercial Distribution

  • 00721902998058 ()

  • 8mm x 16mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971467 RAIL PUNCH 7MMX16MM
MEDTRONIC SOFAMOR DANEK, INC.
6971467
In Commercial Distribution

  • 00721902998034 ()

  • 7mm x 16mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971448 RAIL PUNCH 8MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
6971448
In Commercial Distribution

  • 00721902998027 ()

  • 8mm x 14mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROSTHESIS 0586 CAUSSE/PARAHY FLX HA TOT
MEDTRONIC XOMED, INC.
0586
Not in Commercial Distribution

  • 00721902997969 ()

  • Length: 14.5 Millimeter
  • Head Diameter is 4.0 MM X 1.7 MM
  • Shaft Diameter is 0.6 MM


  • Ossicular prosthesis, total
INSTRUMENT 6971447 RAIL PUNCH 7MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
6971447
In Commercial Distribution

  • 00721902997723 ()

  • 7mm x 14mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971446 RAIL PUNCH 6MMX14MM
MEDTRONIC SOFAMOR DANEK, INC.
6971446
In Commercial Distribution

  • 00721902997716 ()

  • 6mm x 14mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971427 RAIL PUNCH 7MMX12MM
MEDTRONIC SOFAMOR DANEK, INC.
6971427
In Commercial Distribution

  • 00721902997709 ()

  • 7mm x 12mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 6971426 RAIL PUNCH 6MMX12MM
MEDTRONIC SOFAMOR DANEK, INC.
6971426
In Commercial Distribution

  • 00721902997693 ()

  • 6mm x 12mm


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPACER 2980001 THREADED INSERTER
MEDTRONIC SOFAMOR DANEK, INC.
2980001
In Commercial Distribution

  • 00721902996689 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
SPACER 2980003 SLAP PLATE
MEDTRONIC SOFAMOR DANEK, INC.
2980003
In Commercial Distribution

  • 00721902996672 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 2980100 6MM OSTEOTOME
MEDTRONIC SOFAMOR DANEK, INC.
2980100
In Commercial Distribution

  • 00721902996481 ()


  • Orthopaedic osteotome
VER REDUCED BENDING IRON R
MEDTRONIC SOFAMOR DANEK, INC.
X0903035R
In Commercial Distribution

  • 00721902996061 ()


  • Manual orthopaedic bender, reusable
VER REDUCED BENDING IRON L
MEDTRONIC SOFAMOR DANEK, INC.
X0903035L
In Commercial Distribution

  • 00721902996054 ()


  • Manual orthopaedic bender, reusable
CDH SEX MAS-TI-CANN-4.5X50
MEDTRONIC SOFAMOR DANEK, INC.
X8674550
In Commercial Distribution

  • 00721902996030 ()

  • Length: 50.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X45
MEDTRONIC SOFAMOR DANEK, INC.
X8674545
In Commercial Distribution

  • 00721902996023 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X40
MEDTRONIC SOFAMOR DANEK, INC.
X8674540
In Commercial Distribution

  • 00721902996016 ()

  • Length: 40.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X35
MEDTRONIC SOFAMOR DANEK, INC.
X8674535
In Commercial Distribution

  • 00721902996009 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X30
MEDTRONIC SOFAMOR DANEK, INC.
X8674530
In Commercial Distribution

  • 00721902995996 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 30.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X25
MEDTRONIC SOFAMOR DANEK, INC.
X8674525
In Commercial Distribution

  • 00721902995989 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 25.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
CDH SEX MAS-TI-CANN-4.5X20
MEDTRONIC SOFAMOR DANEK, INC.
X8674520
In Commercial Distribution

  • 00721902995972 ()

  • Length: 20.0 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CASE 7056351 CDHL 5.5 ADD ON IMP TRAY TI
MEDTRONIC SOFAMOR DANEK, INC.
7056351
In Commercial Distribution

  • 00721902995866 ()


  • Instrument tray, reusable
CASE 7055351 CDHL 5.5 ADD ON IMP TRAY SS
MEDTRONIC SOFAMOR DANEK, INC.
7055351
In Commercial Distribution

  • 00721902995859 ()


  • Instrument tray, reusable
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