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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Abdominal Binder (4 Panel) Medium
VIVE HEALTH LLC
SUP3013BLKM4P
In Commercial Distribution

  • 10810113570430 ()
  • 00810113570433 ()


  • Abdominal binder, reusable
Abdominal Binder (4 Panel) Small
VIVE HEALTH LLC
SUP3013BLKS4P
In Commercial Distribution

  • 10810113570423 ()
  • 00810113570426 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) 3XL
VIVE HEALTH LLC
SUP3013BLK3XL3P
In Commercial Distribution

  • 10810113570416 ()
  • 00810113570419 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) 2XL
VIVE HEALTH LLC
SUP3013BLK2XL3P
In Commercial Distribution

  • 10810113570409 ()
  • 00810113570402 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) XL
VIVE HEALTH LLC
SUP3013BLKXL3P
In Commercial Distribution

  • 10810113570393 ()
  • 00810113570396 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) Large
VIVE HEALTH LLC
SUP3013BLKL3P
In Commercial Distribution

  • 10810113570386 ()
  • 00810113570389 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) Medium
VIVE HEALTH LLC
SUP3013BLKM3P
In Commercial Distribution

  • 10810113570379 ()
  • 00810113570372 ()


  • Abdominal binder, reusable
Abdominal Binder (3 Panel) Small
VIVE HEALTH LLC
SUP3013BLKS3P
In Commercial Distribution

  • 10810113570362 ()
  • 00810113570365 ()


  • Abdominal binder, reusable
TABLE POST WITHOUT PANEL BOX
Surgipros, LLC
50-4581SP
In Commercial Distribution

  • 00810143900866 ()


  • Surgical retraction system mounting frame, reusable
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
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
iScreen BUP Panel(Urine) 25T
Instant Technologies, Inc.
DBU-114
In Commercial Distribution

  • 30817405021919 ()
  • 00817405021918 ()
  • 10817405021915 ()
DBU-114

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

  • 30817405021711 ()
  • 00817405021710 ()
  • 10817405021717 ()
DPC-114

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

  • 30817405021483 ()
  • 00817405021482 ()
  • 10817405021489 ()
  • 00817405021123 ()
DMD-114

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

  • 30817405021476 ()
  • 00817405021475 ()
  • 10817405021472 ()
DBA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DISPOSABLE TOP FOLD X-RAY PANEL/
Techno-Aide, Inc.
CCM-10
In Commercial Distribution

  • G242CCM1091 ()
  • G242CCM109 ()
CCM-10

  • Medical equipment/instrument drape, single-use
DISPOSABLE TOP FOLD X-RAY PANEL/
Techno-Aide, Inc.
CCL-14
In Commercial Distribution

  • G242CCL1491 ()
  • G242CCL149 ()
CCL-14

  • Medical equipment/instrument drape, single-use
TOP FOLD X-RAY PANEL/RECEPTOR/
Techno-Aide, Inc.
CCC-DR
In Commercial Distribution

  • G242CCCDR91 ()
  • G242CCCDR9 ()
CCC-DR

  • Medical equipment/instrument drape, single-use
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
Shoulder Chair Panel Pad, Left
SCHUERCH CORPORATION
508-1460
In Commercial Distribution

  • 00810057371363 ()


  • Operating table patient pressure distribution pad, reusable
Shoulder Chair Panel Pad, Right
SCHUERCH CORPORATION
508-1459
In Commercial Distribution

  • 00810057371356 ()


  • Operating table patient pressure distribution pad, reusable
KIT, PANEL, ERGONOMIC PENDANT HOLDER
JOERNS HEALTHCARE, LLC
N106
In Commercial Distribution

  • 00810055882540 ()
N106

  • Basic electric hospital bed
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
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
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