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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QC Sets and Panels: KWIK-STIK™ GBS Verification Panel (Live Culture)
MICROBIOLOGICS INC.
8173
In Commercial Distribution

  • 70845357035676 ()
8173

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel
MICROBIOLOGICS INC.
8268
In Commercial Distribution

  • 70845357044364 ()
8268

  • SARS-CoV-2 nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Multiplex Vaginal Verification Panel
MICROBIOLOGICS INC.
8245
In Commercial Distribution

  • 70845357043695 ()
8245

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Cdiff Verification Panel (Live Culture)
MICROBIOLOGICS INC.
8243
In Commercial Distribution

  • 70845357043329 ()
8243

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
12 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-6124A3
In Commercial Distribution

  • 20816490022989 ()
  • 10816490022982 ()
  • 00816490022985 ()
DOAY-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-2135A3
In Commercial Distribution

  • 20816490022880 ()
  • 10816490022883 ()
  • 00816490022886 ()
DOAY-2135A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-1145A3
In Commercial Distribution

  • 20816490022866 ()
  • 10816490022869 ()
  • 00816490022862 ()
DOAY-1145A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-1144A3
In Commercial Distribution

  • 20816490022859 ()
  • 10816490022852 ()
  • 00816490022855 ()
DOAY-1144A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-6125A3
In Commercial Distribution

  • 20816490022637 ()
  • 10816490022630 ()
  • 00816490022633 ()
HCDOAEW-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEC-6125A3
In Commercial Distribution

  • 20816490022477 ()
  • 10816490022470 ()
  • 00816490022473 ()
HCDOAEC-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-264A3
In Commercial Distribution

  • 20816490023733 ()
  • 10816490023736 ()
  • 00816490023739 ()
HCDOAEW-264A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HCDOAEW-2135A3
In Commercial Distribution

  • 20816490023351 ()
  • 10816490023354 ()
  • 00816490023357 ()
HCDOAEW-2135A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
DOAY-6125A3
In Commercial Distribution

  • 20816490023009 ()
  • 10816490023002 ()
  • 00816490023005 ()
DOAY-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC
AMEDITECH INC.
IMC-7P
Not in Commercial Distribution

  • 00816565020168 ()
IMC-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20
Instant Technologies, Inc.
ABTOFCUBE0502B
In Commercial Distribution

  • 30817405024057 ()
  • 00817405024056 ()
  • 10817405024053 ()
ABTOFCUBE0502B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel E&I Oral Click Cube AMP50, COC20, MET50, OPI40
Instant Technologies, Inc.
ABTOFCUBE0401A
In Commercial Distribution

  • 30817405023944 ()
  • 00817405023943 ()
  • 10817405023940 ()
ABTOFCUBE0401A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel CLIA Waived Click Cup BUP10, BZO300, COC300, MOP300, MTD300
Instant Technologies, Inc.
ABTDOAW15702B
In Commercial Distribution

  • 30817405023869 ()
  • 00817405023868 ()
  • 10817405023865 ()
ABTDOAW15702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel CLIA Waived Click Cup AMP1000/COC300/MET1000/MOP300/OXY100
Instant Technologies, Inc.
ABTDOAW15701A
In Commercial Distribution

  • 30817405023852 ()
  • 00817405023851 ()
  • 10817405023858 ()
ABTDOAW15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/PCP10
Instant Technologies, Inc.
ABTOFCUBE0501A
In Commercial Distribution

  • 30817405023517 ()
  • 00817405023516 ()
  • 10817405023513 ()
ABTOFCUBE0501A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50
Instant Technologies, Inc.
ABTDOAK15701A
In Commercial Distribution

  • 30817405023494 ()
  • 00817405023493 ()
  • 10817405023490 ()
ABTDOAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel
EXACT MEDICAL MANUFACTURING, INC.
HemviewCSD1003S
In Commercial Distribution

  • 26975424195237 ()
  • 06975424195233 ()
HemviewCSD1003S

  • Patient surgical drape, single-use
5 Tests/Kit;6 Panel;AMP50,BZO50,COC50,MET25,OPI40,THC50
Eterbio, Inc.
ETG019005
In Commercial Distribution

  • 06977469280219 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FEMORAL ANGIO DRAPE W/CLEAR POLY PANEL, 86 X 135, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426099202 ()
  • 00748426099207 ()


  • Patient surgical drape, single-use, non-sterile
No Description
BREG, INC.
EXTENSION PANEL, PINNACLE BELT
In Commercial Distribution

  • 00672736136867 ()
SP20010-000

  • Lumbar spine orthosis
No Description
BREG, INC.
EXTENSION PANEL, ASCEND BELT
In Commercial Distribution

  • 00672736136775 ()
SP10010-000

  • Lumbar spine orthosis
No Description
J. W. HARRIS CO., INC.
REG,723C-050P PANEL MT
In Commercial Distribution

  • 00850005066538 ()
3500750

  • Medical air cylinder regulator
No Description
J. W. HARRIS CO., INC.
REG,723C-015LPM PANEL MT
In Commercial Distribution

  • 00850005066521 ()
3500749

  • Medical air cylinder regulator
No Description
LivaNova Deutschland GmbH
Panel 6 pos. (S5)
In Commercial Distribution

  • 04033817900788 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 3 pos. (S5)
In Commercial Distribution

  • 04033817900771 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 5 pos. (S5)
In Commercial Distribution

  • 04033817900764 ()


  • Cardiopulmonary bypass system, roller type
No Description
LivaNova Deutschland GmbH
Panel 4 pos. (S5)
In Commercial Distribution

  • 04033817900757 ()


  • Cardiopulmonary bypass system, roller type
The Triple Spindle Dual Flat Panel Monitor Light Head with Video Single Flat Panel Monitor 11008910 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170516 ()
LGH00052

  • Medical monitor/light mount
The Triple Spindle Single Flat Panel Monitor Light Head with Video Single Flat Panel Monitor 11008902 G-Series is used with the HarmonyAIR G-Series Suspension System.
STERIS CORPORATION
G-Series Suspension
Not in Commercial Distribution

  • 00724995170431 ()
LGH00051

  • Medical monitor/light mount
Assisted Reproduction Microtools (Pipettes)
Coopersurgical, Inc.
145µm
In Commercial Distribution

  • 05060488047251 ()
7-72-3145/20

  • HLA class II antibody identification panel IVD, kit, multiplex
E SERIES DL LT Single Flat Panel Monitor AUX Single Flat Panel Monitor is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995172152 ()
LES03

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
Motor Controller for Built-in solutions
W & H Dentalwerk Bürmoos GmbH
30278000
In Commercial Distribution

  • J021302780000 ()
  • J021302780001 ()


  • Dental delivery system instrument unit, electric
  • Dental surgical power tool motor, electric
Display Performance
W & H Dentalwerk Bürmoos GmbH
30244000
In Commercial Distribution

  • J021302440000 ()
  • J021302440001 ()


  • Dental surgical power tool motor, electric
  • Dental delivery system instrument unit, electric
Supply Hose
W & H Dentalwerk Bürmoos GmbH
30180003
In Commercial Distribution

  • J021301800031 ()


  • Dental delivery system instrument unit, electric
  • Dental surgical power tool motor, electric
Electric Handpiece Motor
W & H Dentalwerk Bürmoos GmbH
30178000
In Commercial Distribution

  • J021301780001 ()


  • Dental surgical power tool motor, electric
  • Dental delivery system instrument unit, electric
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