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 3 COC/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020010
In Commercial Distribution

  • 10858904006195 ()
  • 00858904006198 ()
DOA-434-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MET Panel(Urine) 25T
Instant Technologies, Inc.
DMA-114
In Commercial Distribution

  • 30817405022473 ()
  • 00817405022472 ()
  • 10817405022479 ()
DMA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MOP Panel(Urine) 25T
Instant Technologies, Inc.
DMO-114
In Commercial Distribution

  • 30817405022466 ()
  • 00817405022465 ()
  • 10817405022462 ()
DMO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OPI Panel(Urine) 25T
Instant Technologies, Inc.
DOP-114
In Commercial Distribution

  • 30817405022459 ()
  • 00817405022458 ()
  • 10817405022455 ()
DOP-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen TCA Panel(Urine) 25T
Instant Technologies, Inc.
DTC-114
In Commercial Distribution

  • 30817405022442 ()
  • 00817405022441 ()
  • 10817405022448 ()
DTC-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC Panel(Urine) 25T
Instant Technologies, Inc.
DCO-114
In Commercial Distribution

  • 30817405022435 ()
  • 00817405022434 ()
  • 10817405022431 ()
DCO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen AMP Panel(Urine) 25T
Instant Technologies, Inc.
DAM-114
In Commercial Distribution

  • 30817405022428 ()
  • 00817405022427 ()
  • 10817405022424 ()
DAM-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen THC Panel(Urine) 25T
Instant Technologies, Inc.
DTH-114
In Commercial Distribution

  • 30817405022312 ()
  • 00817405022311 ()
  • 10817405022318 ()
DTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OXY Panel(Urine) 25T
Instant Technologies, Inc.
DOX-114
In Commercial Distribution

  • 30817405022305 ()
  • 00817405022304 ()
  • 10817405022301 ()
DOX-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MTD Panel(Urine) 25T
Instant Technologies, Inc.
DMT-114
In Commercial Distribution

  • 30817405022299 ()
  • 00817405022298 ()
  • 10817405022295 ()
DMT-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BZO Panel(Urine) 25T
Instant Technologies, Inc.
DBZ-114
In Commercial Distribution

  • 30817405022282 ()
  • 00817405022281 ()
  • 10817405022288 ()
DBZ-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MET500 Panel(Urine) 25T
Instant Technologies, Inc.
DMA-U114
In Commercial Distribution

  • 30817405022084 ()
  • 00817405022083 ()
  • 10817405022080 ()
DMA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC150 Panel(Urine) 25T
Instant Technologies, Inc.
DCO-U114
In Commercial Distribution

  • 30817405022077 ()
  • 00817405022076 ()
  • 10817405022073 ()
DCO-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Live View Panel Version 1.4
Neurotronics, LLC
1.4
In Commercial Distribution

  • 00817111020816 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
Live View Panel Version 1.3
Neurotronics, LLC
1.3
Not in Commercial Distribution

  • 00817111020786 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
17X17 flat Panel Detector (CsI)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN253
In Commercial Distribution

  • 00817100020452 ()


  • Diagnostic x-ray digital imaging conversion system
17X17 Flat Panel Detector (GOS)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN252
In Commercial Distribution

  • 00817100020445 ()


  • Diagnostic x-ray digital imaging conversion system
SMS 14X17 Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN251
In Commercial Distribution

  • 00817100020322 ()


  • Diagnostic x-ray digital imaging conversion system
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HCVAMR
In Commercial Distribution

  • 00812242030215 ()
HCVAMR

  • Hepatitis C virus nucleic acid IVD, calibrator
HIV-1 Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HIVAMR
In Commercial Distribution

  • 00812242030208 ()
HIVAMR

  • HIV1 nucleic acid IVD, calibrator
DELTA 1.7MM PANEL 22X22 CTRSINKSX0.75MM
Stryker Leibinger GmbH & Co. KG
70-92053
In Commercial Distribution

  • 07613327090185 ()

  • 3D Plates: 22x22 Holes
  • Thickness: 0.75 Millimeter
70-92053

  • Craniofacial fixation plate, bioabsorbable
Assayed MRSA NxG Control Panel
MICROBIOLOGICS INC.
8195 Cepheid Xpert® MRSA NxG Control Panel
In Commercial Distribution

  • 70845357041226 ()
8195

  • MRSA nucleic acid IVD, control
Assayed GBS LB Control Panel
MICROBIOLOGICS INC.
8194 Cepheid Xpert® GBS LB Control Panel
Not in Commercial Distribution

  • 70845357041219 ()
8194

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Assayed CT/NG Control Panel
MICROBIOLOGICS INC.
8188 Cepheid Xpert® CT/NG Control Panel
In Commercial Distribution

  • 70845357041189 ()
8188

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
TABLE POST WITHOUT PANEL BOX
Surgipros, LLC
50-4581SP
In Commercial Distribution

  • 00810143900866 ()


  • Surgical retraction system mounting frame, reusable
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
Single Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDMD-101
In Commercial Distribution

  • 20816490023863 ()
  • 10816490023866 ()
  • 00816490023869 ()
HDMD-101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1164
In Commercial Distribution

  • 20816490023849 ()
  • 10816490023842 ()
  • 00816490023845 ()
HDOA-1164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1864
In Commercial Distribution

  • 20816490023634 ()
  • 10816490023637 ()
  • 00816490023630 ()
HDOA-1864

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
GBTHC-101a
In Commercial Distribution

  • 20816490023542 ()
  • 10816490023545 ()
  • 00816490023548 ()
GBTHC-101a

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel DOA Test Strip
Healgen Scientific Limited Liability Company
GBOPI-101a
In Commercial Distribution

  • 20816490023535 ()
  • 10816490023538 ()
  • 00816490023531 ()
GBOPI-101a

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-535
In Commercial Distribution

  • 20816490023436 ()
  • 10816490023439 ()
  • 00816490023432 ()
HDOA-535

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1454
In Commercial Distribution

  • 20816490023115 ()
  • 10816490023118 ()
  • 00816490023111 ()
HDOA-1454

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-1575
In Commercial Distribution

  • 20816490023047 ()
  • 10816490023040 ()
  • 00816490023043 ()
HDOA-1575

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Cup
Healgen Scientific Limited Liability Company
DOAY-4124
In Commercial Distribution

  • 20816490022941 ()
  • 10816490022944 ()
  • 00816490022947 ()
DOAY-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Cup;
Healgen Scientific Limited Liability Company
DOAY-3104
In Commercial Distribution

  • 20816490022910 ()
  • 10816490022913 ()
  • 00816490022916 ()
DOAY-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test Cup
Healgen Scientific Limited Liability Company
DOAY-264
In Commercial Distribution

  • 20816490022897 ()
  • 10816490022890 ()
  • 00816490022893 ()
DOAY-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
DOAY-2135
In Commercial Distribution

  • 20816490022873 ()
  • 10816490022876 ()
  • 00816490022879 ()
DOAY-2135

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