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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5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
Zerochaos
60505-3 ZC
Not in Commercial Distribution

  • B539605053ZC0 ()
60505-3 ZC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
GOWN,SURG,XALT,L3,PANEL CVR,GREEN,XL
MEDLINE INDUSTRIES, INC.
MDTGXP3JXL
In Commercial Distribution

  • 30884389189218 ()
  • 10884389189214 ()
MDTGXP3JXL

  • Surgical gown, reusable
CVi bed mount control panel, p/n 700130-005
ACIST MEDICAL SYSTEMS, INC.
014607
In Commercial Distribution

  • 30841716101022 ()


  • Angiography contrast medium injection system, line-powered, mobile
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,L
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OL
In Commercial Distribution

  • 20888277418162 ()
  • 10888277418165 ()
MDTAUSGXP4OL

  • Surgical gown, reusable
GOWN,SURG,XALT,L4,PANEL CVR,OBLUE,XL
MEDLINE INDUSTRIES, INC.
MDTAUSGXP4OXL
In Commercial Distribution

  • 20888277418179 ()
  • 10888277418172 ()
MDTAUSGXP4OXL

  • Surgical gown, reusable
Sample Collection Kit, Blood (Adx Dual), Liver Panel
Cue Health Inc.
C2233
In Commercial Distribution

  • 00810040821080 ()


  • Capillary blood collection kit IVD
Sample Collection Kit, Blood (Adx Single), Kidney Panel
Cue Health Inc.
C2236
In Commercial Distribution

  • 00810040821004 ()


  • Capillary blood collection kit IVD
Drugs of Abuse Test 10-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-8105A3
In Commercial Distribution

  • 40612479228823 ()
  • 20612479228812 ()
  • 10612479231013 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 14-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-1145A3
In Commercial Distribution

  • 40612479228809 ()
  • 20612479228799 ()
  • 10612479231006 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-6125A3
In Commercial Distribution

  • 40612479228786 ()
  • 20612479228775 ()
  • 10612479230993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test 12-Drug Panel with Adulterants:
MCKESSON MEDICAL-SURGICAL INC.
16-5125A3
In Commercial Distribution

  • 40612479228762 ()
  • 20612479228751 ()
  • 10612479230986 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426025269 ()
  • 00748426025268 ()
  • 50748426025263 ()


  • Instrument/equipment drape, single-use, sterile
PANEL DRAPE W/ADHESIVE 30 X 24, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 30748426068969 ()
  • 00748426068968 ()
  • 50748426068963 ()


  • Instrument/equipment drape, single-use, sterile
GENESIS II FEMORAL TRIALS L TRAY PANEL SIZE1-6
Smith & Nephew, Inc.
71442197
In Commercial Distribution

  • 00885556625354 ()
71442197

  • Instrument tray, reusable
The ATLAS Headbox Expansion Panel is an accessory to the ATLAS Neurophysiology System and ATLAS Stim Headbox. The HEP is a power module and a signal splitter.
NEURALYNX, INC.
ATLAS HEP
In Commercial Distribution

  • 00850011306512 ()
31-0607-0014

  • Electroencephalographic signal amplifier
  • Somatosensory electrical stimulation system
No Description
REMEL EUROPE LIMITED
R62400
In Commercial Distribution

  • 05056080501680 ()


  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5889
In Commercial Distribution

  • 00613745058894 ()

  • 100 tests
5889

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5825
In Commercial Distribution

  • 00613745058252 ()

  • 25 tests
5825

  • Multiple thyroid antibody IVD, kit, enzyme immunoassay (EIA)
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5489
In Commercial Distribution

  • 00613745054896 ()

  • 100 tests
5489

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5425
In Commercial Distribution

  • 00613745054254 ()

  • 25 tests
5425

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5189
In Commercial Distribution

  • 00613745051895 ()

  • 100 tests
5189

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5125
In Commercial Distribution

  • 00613745051253 ()

  • 25 tests
5125

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
No Description
Bird & Cronin, LLC
0818ABB4P72
In Commercial Distribution

  • 00610570167685 ()
  • 00610570158805 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P45
In Commercial Distribution

  • 00610570167661 ()
  • 00610570158782 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P72
In Commercial Distribution

  • 00610570167654 ()
  • 00610570158775 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P62
In Commercial Distribution

  • 00610570167647 ()
  • 00610570158768 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB3P45
In Commercial Distribution

  • 00610570167623 ()
  • 00610570158751 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P96
In Commercial Distribution

  • 00610570167692 ()
  • 00610570158812 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
0818ABB4P62
In Commercial Distribution

  • 00610570167678 ()
  • 00610570158799 ()


  • Abdominal binder, single-use
A wound cover extension panel for oversized legs that aids in the extension of the exucare which wraps around the leg which is intended to be used as an initial, short-term treatment after injury that consists of an high drainage absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC5051-01
In Commercial Distribution

  • 00850051939046 ()
ECXHD

  • First aid absorbent pad/bandage
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