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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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
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
GENESIS II FEMORAL TRIALS L TRAY PANEL SIZE1-6
Smith & Nephew, Inc.
71442197
In Commercial Distribution

  • 00885556625354 ()
71442197

  • Instrument tray, reusable
Cotinine (COT) Rapid Test Panel box of 40
Hangzhou AllTest Biotech Co., Ltd.
DCT-114
In Commercial Distribution

  • 06970277512527 ()
  • 06970277512510 ()
DCT-114

  • Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)
The Single Flat Panel Monitor, Single Flat Panel Monitor Spindle G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995166748 ()
LGH00043

  • Medical monitor/light mount
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
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
No Description
REMEL EUROPE LIMITED
R62400
In Commercial Distribution

  • 05056080501680 ()


  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1828
Not in Commercial Distribution

  • 04953170291470 ()
N3626130

  • Touchscreen
A wound cover wider 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 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.
EC4560
In Commercial Distribution

  • 00856525007990 ()
ECXW

  • First aid absorbent pad/bandage
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
21
In Commercial Distribution

  • 00856181003213 ()


  • Headphones
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
APPLIED BIOCODE, INC.
01
In Commercial Distribution

  • 00851034007073 ()
63-R0001

  • Multiple-type respiratory pathogen nucleic acid IVD, control
No Description
GERMAINE LABORATORIES, INC
44433
In Commercial Distribution

  • 00695684444310 ()
  • 00695684444334 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Radiologic table
Philips Medical Systems DMC GmbH
9890-010-88161
Not in Commercial Distribution

  • 00884838074286 ()
712031

  • Computed radiography digital imaging scanner
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
UTAK LABORATORIES, INC.
PM PAN COM V9
In Commercial Distribution

  • B80002942500010 ()
  • B80002942500011 ()
  • B80002942500012 ()
  • B80002942500013 ()
  • B80002942500016 ()
  • B80002942500017 ()
  • B80002942500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
Detection of Syphilis, 10 samples
ARLINGTON SCIENTIFIC, INC.
NC-907000
In Commercial Distribution

  • 00816057020980 ()

  • Total Volume: 0.5 Milliliter
NC-907000

  • Treponema pallidum reagin antibody IVD, kit, agglutination
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution

  • 00817830022672 ()

  • Length: 75 Millimeter
07RD-7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-04
In Commercial Distribution

  • 00817830022658 ()

  • Length: 75 Millimeter
07RD-7073-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP/BAR/BUP/BZD/COC/M-AMP/MTD/OPI/OXY/THC
RAPID DIAGNOSTICS INC
07RD7073-03
In Commercial Distribution

  • 00817830022252 ()

  • Length: 75 Millimeter
07RD7073-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7073-01A
In Commercial Distribution

  • 00817830022245 ()

  • Length: 75 Millimeter
07RD7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7073-01
In Commercial Distribution

  • 00817830022238 ()

  • Length: 75 Millimeter
07RD7073-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7072-06
In Commercial Distribution

  • 00817830022221 ()

  • Length: 75 Millimeter
07RD7072-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7072-02A
In Commercial Distribution

  • 00817830022214 ()

  • Length: 75 Millimeter
07RD7072-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7072-02
In Commercial Distribution

  • 00817830022207 ()

  • Length: 75 Millimeter
07RD7072-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01A
In Commercial Distribution

  • 00817830022191 ()

  • Length: 75 Millimeter
07RD7072-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7072-01
In Commercial Distribution

  • 00817830022184 ()

  • Length: 75 Millimeter
07RD7072-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7071-12
In Commercial Distribution

  • 00817830022177 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-05
In Commercial Distribution

  • 00817830022160 ()

  • Length: 75 Millimeter
07RD7071-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04A
In Commercial Distribution

  • 00817830022153 ()

  • Length: 75 Millimeter
07RD7071-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04
In Commercial Distribution

  • 00817830022146 ()

  • Length: 75 Millimeter
07RD7071-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7071-03A
In Commercial Distribution

  • 00817830022139 ()

  • Length: 75 Millimeter
07RD7071-03A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-03
In Commercial Distribution

  • 00817830022122 ()

  • Length: 75 Millimeter
07RD7071-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-02A
In Commercial Distribution

  • 00817830022115 ()

  • Length: 75 Millimeter
07RD7071-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-02
In Commercial Distribution

  • 00817830022108 ()

  • Length: 75 Millimeter
07RD7071-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7071-01A
In Commercial Distribution

  • 00817830022092 ()

  • Length: 75 Millimeter
07RD7071-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-01
In Commercial Distribution

  • 00817830022085 ()

  • Length: 75 Millimeter
07RD7071-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-08
In Commercial Distribution

  • 00817830022078 ()

  • Length: 75 Millimeter
07RD7070-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD7070-07
In Commercial Distribution

  • 00817830022061 ()

  • Length: 75 Millimeter
07RD7070-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7070-06
In Commercial Distribution

  • 00817830022054 ()

  • Length: 75 Millimeter
07RD7070-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-05A
In Commercial Distribution

  • 00817830022047 ()

  • Length: 75 Millimeter
07RD7070-05A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-05
In Commercial Distribution

  • 00817830022030 ()

  • Length: 75 Millimeter
07RD7070-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7070-04A
In Commercial Distribution

  • 00817830022023 ()

  • Length: 75 Millimeter
07RD7070-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-04
In Commercial Distribution

  • 00817830022016 ()

  • Length: 75 Millimeter
07RD7070-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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