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 Single Drug Test Cassette (MOP) - 40 tests/ kit are for the qualitative detection of morphine in urine.
BTNX Inc
MOP-1C3-40
In Commercial Distribution

  • 00722066000595 ()
  • 00722066005033 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Drug Test Strip - 100/kitMorphine (MOP) - Cut-off 300 ng/ml
BTNX Inc
MOP-1S3-100
In Commercial Distribution

  • 00722066000588 ()
  • 00722066004920 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassette (MET) - 40 tests/ kit are for the qualitative detection of methamphetamine in urine.
BTNX Inc
MET-1C2-40
In Commercial Distribution

  • 00722066000571 ()
  • 00722066005026 ()
MET-1C2-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Drug Test Strip - 100/kitMethamphetamine (MET) - Cut off 1000 ng/ml
BTNX Inc
MET-1S2-100
In Commercial Distribution

  • 00722066000564 ()
  • 00722066004937 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassettes (MDMA) - 40 tests/ kit are for qualitative detection of 3,4-Methylenedioxy-Methamphetamine in urine.
BTNX Inc
MDM-1C9-40
In Commercial Distribution

  • 00722066000557 ()
  • 00722066003824 ()
MDM-1C9-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Strips (MDMA) - 100 tests/ kit are for the qualitative detection of 3,4-Methylenedioxy-Methamphetamine in urine.
BTNX Inc
MDM-1S9-100
In Commercial Distribution

  • 00722066000540 ()
  • 00722066003831 ()
MDM-1S9-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassettes (COC) - 40 tests/ kit are for the qualitative detection of cocaine metabolite in urine.
BTNX Inc
COC-1C3-40
In Commercial Distribution

  • 00722066000533 ()
  • 00722066003800 ()
COC-1C3-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Strips (COC) - 100 tests/ kit are for the qualitative detection of cocaine metabolite in urine.
BTNX Inc
COC-1S3-100
In Commercial Distribution

  • 00722066000526 ()
  • 00722066003817 ()
COC-1S3-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassettes (BZO) - 40 tests/ kit are for the qualitative detection of Benzodiazepines in urine.
BTNX Inc
BZO-1C3-40
In Commercial Distribution

  • 00722066000519 ()
  • 00722066003909 ()
BZO-1C3-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Strips (BZO) - 100 tests/ kit are for the qualitative detection of Benzodiazipines in urine.
BTNX Inc
BZO-1S3-100
In Commercial Distribution

  • 00722066000502 ()
  • 00722066003916 ()
BZO-1S3-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Drug Test Cassette - 40/kit Buprenorphine (BUP) - Cut off 10 ng/ml
BTNX Inc
BUP-1C5-40
In Commercial Distribution

  • 00722066000496 ()
  • 00722066004777 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Drug Test Strip - 100/kit - Buprenorphine
BTNX Inc
BUP-1S5-100
Not in Commercial Distribution

  • 00722066000489 ()
  • 00722066004715 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Strips (AMP) - 100 tests/ kit are for the qualitative detection of Amphetamine 1000 ng/ml in urine.
BTNX Inc
AMP-1S2-100
In Commercial Distribution

  • 00722066000458 ()
  • 00722066003930 ()
AMP-1S2-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassettes (Amphetamine) - 40 tests/ kit are for the qualitative detection of Amphetamine in urine.
BTNX Inc
AMP-1C2-40
In Commercial Distribution

  • 00722066000441 ()
  • 00722066003923 ()
AMP-1C2-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite, Ketone and pH in urine.
BTNX Inc
U7.1-1S100
In Commercial Distribution

  • 00722066000380 ()
  • 00722066003770 ()
U7.1-1S100

  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite in urine.
BTNX Inc
U5.1-1S100
In Commercial Distribution

  • 00722066000373 ()
  • 00722066003763 ()
U5.1-1S100

  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
Rapid Response 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein in urine.
BTNX Inc
U4.1-1S100
In Commercial Distribution

  • 00722066000366 ()
  • 00722066003756 ()
U4.1-1S100

  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
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
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