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: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
IDUN SOLUTIONS LLC
41511104001034
In Commercial Distribution

  • 90857275007837 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8228
In Commercial Distribution

  • 70845357042681 ()
8228

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inactivated)
MICROBIOLOGICS INC.
8201
Not in Commercial Distribution

  • 70845357041486 ()
8201

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8181
In Commercial Distribution

  • 70845357041431 ()
8181

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8180
In Commercial Distribution

  • 70845357041424 ()
8180

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8189
In Commercial Distribution

  • 70845357041196 ()
8189

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8187
In Commercial Distribution

  • 70845357041172 ()
8187

  • Multiple bacteria carbapenemase nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Control Panel (Inactivated)
MICROBIOLOGICS INC.
8215
Not in Commercial Distribution

  • 70845357041165 ()
8215

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification (BCID) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5229P
Not in Commercial Distribution

  • 70845357038899 ()
5229P

  • Multiple bacteria species culture isolate identification control IVD, kit
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Natura+ Urostomy Small Pouch With Soft Tap, Transparent 1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
421074
Not in Commercial Distribution

  • 10768455133342 ()
  • 00768455133345 ()
  • 00768455189700 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
413439
In Commercial Distribution

  • 10768455128898 ()
  • 00768455128891 ()
  • 00768455187652 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
413438
In Commercial Distribution

  • 10768455128874 ()
  • 00768455128877 ()
  • 00768455187645 ()


  • Multiple-piece urostomy bag, open-ended
Natura+ Urostomy Pouch With Soft Tap, Transparent With 1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
413437
In Commercial Distribution

  • 10768455128850 ()
  • 00768455128853 ()
  • 00768455187638 ()


  • Multiple-piece urostomy bag, open-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Large
CONVATEC, PURCHASING DEPARTMENT
416783
In Commercial Distribution

  • 10768455114693 ()
  • 00768455114696 ()
  • 00768455188703 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Large
CONVATEC, PURCHASING DEPARTMENT
416782
In Commercial Distribution

  • 10768455114686 ()
  • 00768455114689 ()
  • 00768455188697 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Medium
CONVATEC, PURCHASING DEPARTMENT
416781
In Commercial Distribution

  • 10768455114679 ()
  • 00768455114672 ()
  • 00768455188680 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Medium
CONVATEC, PURCHASING DEPARTMENT
416778
In Commercial Distribution

  • 10768455114648 ()
  • 00768455114641 ()
  • 00768455188659 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416777
In Commercial Distribution

  • 10768455114631 ()
  • 00768455114634 ()
  • 00768455188642 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Mini Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416776
In Commercial Distribution

  • 10768455114624 ()
  • 00768455114627 ()
  • 00768455188635 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / Two-Sided Comfort Panel / Opaque / Small
CONVATEC, PURCHASING DEPARTMENT
416775
In Commercial Distribution

  • 10768455114617 ()
  • 00768455114610 ()
  • 00768455188628 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Small
CONVATEC, PURCHASING DEPARTMENT
416774
In Commercial Distribution

  • 10768455114600 ()
  • 00768455114603 ()
  • 00768455188611 ()


  • Multiple-piece intestinal ostomy bag, closed-ended
Esteem Synergy, 14 in., Drainable Pouch with 1 Sided Comfort Panel, Transparent, Straight, Extra-Large
CONVATEC, PURCHASING DEPARTMENT
405406
Not in Commercial Distribution

  • 10768455104779 ()
  • 00768455104772 ()
  • 80768455104778 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401532
Not in Commercial Distribution

  • 10768455103499 ()
  • 00768455103492 ()
  • 80768455103498 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401531
Not in Commercial Distribution

  • 10768455103482 ()
  • 00768455103485 ()
  • 80768455103481 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401530
Not in Commercial Distribution

  • 10768455103475 ()
  • 00768455103478 ()
  • 80768455103474 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401529
Not in Commercial Distribution

  • 10768455103468 ()
  • 00768455103461 ()
  • 80768455103467 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401524
Not in Commercial Distribution

  • 10768455103413 ()
  • 00768455103416 ()
  • 80768455103412 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 1/4 in
CONVATEC, PURCHASING DEPARTMENT
401523
Not in Commercial Distribution

  • 10768455103406 ()
  • 00768455103409 ()
  • 80768455103405 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 3/4 in
CONVATEC, PURCHASING DEPARTMENT
401522
Not in Commercial Distribution

  • 10768455103390 ()
  • 00768455103393 ()
  • 80768455103399 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 1/2 in
CONVATEC, PURCHASING DEPARTMENT
401521
Not in Commercial Distribution

  • 10768455103383 ()
  • 00768455103386 ()
  • 80768455103382 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 3/4"
CONVATEC, PURCHASING DEPARTMENT
401514
In Commercial Distribution

  • 10768455103369 ()
  • 00768455103362 ()
  • 00768455182534 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 2 1/4"
CONVATEC, PURCHASING DEPARTMENT
401513
In Commercial Distribution

  • 10768455103352 ()
  • 00768455103355 ()
  • 00768455182527 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 3/4"
CONVATEC, PURCHASING DEPARTMENT
401512
In Commercial Distribution

  • 10768455103345 ()
  • 00768455103348 ()
  • 00768455182510 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/2"
CONVATEC, PURCHASING DEPARTMENT
401511
In Commercial Distribution

  • 10768455103338 ()
  • 00768455103331 ()
  • 00768455182503 ()


  • Multiple-piece urostomy bag, open-ended
SUR-FIT Natura® Drainable Pouch, 12" Tran W/1-Sided Comfort Panel, 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401510
In Commercial Distribution

  • 10768455103321 ()
  • 00768455103324 ()
  • 00768455182497 ()


  • Multiple-piece urostomy bag, open-ended
8 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP
UCP BIOSCIENCES, INC.
U-CUP-184-RCN
In Commercial Distribution

  • 20817038020665 ()
  • 10817038020668 ()
  • 00817038020661 ()
U-CUP-184-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823350
Not in Commercial Distribution

  • 07611969965717 ()


  • HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969965700 ()


  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823350
Not in Commercial Distribution

  • 07611969952946 ()
823350

  • HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution

  • 07611969952939 ()
823300

  • HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)
No Description
Guangzhou Berrcom Medical Device Co., Ltd
NC005
In Commercial Distribution

  • 16947656115188 ()
  • 06947656115181 ()


  • HLA class II antibody identification panel IVD, kit, enzyme immunoassay (EIA)
MasteRad MX-30 Radiographic System
Medicatech Usa, Inc.
MasteRad MX30
In Commercial Distribution

  • 00860001404753 ()
MasteRad MX30

  • Stationary basic diagnostic x-ray system, digital
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx - Kit (Boxes 1 through 4)
Pillar Biosciences, Inc.
HDA-LC-2001-48
In Commercial Distribution

  • 00860001218282 ()
HDA-LC-2001-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.
Pillar Biosciences, Inc.
HDA-LC-2001-48-4
In Commercial Distribution

  • 00860001218251 ()
HDA-LC-2001-48-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 3 of 4. This box contains Purification Beads.
Pillar Biosciences, Inc.
HDA-LC-2001-48-3
In Commercial Distribution

  • 00860001218244 ()
HDA-LC-2001-48-3

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
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