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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EQ 4 PANEL DRUG TEST
WAL-MART STORES, INC.
572627440
In Commercial Distribution

  • 00681131089852 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
EQ 1 PANEL DRUG TEST
WAL-MART STORES, INC.
572627458
In Commercial Distribution

  • 00681131089791 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage® Micro Parasite Panel
ALERE SAN DIEGO, INC.
96100
Not in Commercial Distribution

  • 00893038002180 ()
96100

  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
0.8% RESOLVE PANEL C 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902319
In Commercial Distribution

  • 10758750007691 ()
6902319

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL B 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902318
In Commercial Distribution

  • 10758750007684 ()
6902318

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL A 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902317
In Commercial Distribution

  • 10758750007677 ()
6902317

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
PANEL 03 COC150/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020194
In Commercial Distribution

  • 10858904006560 ()
  • 00858904006563 ()
DOA-134-951

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 03 COC150/MAMP500/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020193
In Commercial Distribution

  • 10858904006553 ()
  • 00858904006556 ()
DOA-134-571

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 COC/M-AMP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020009
In Commercial Distribution

  • 10858904006201 ()
  • 00858904006204 ()
DOA-234-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 M-AMP/COC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020014
In Commercial Distribution

  • 10858904006218 ()
  • 00858904006211 ()
DOA-534-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
PANEL 3 M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020011
In Commercial Distribution

  • 10858904006188 ()
  • 00858904006181 ()
DOA-334-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Flat Panel Fluoroscopy Registration Fixture
GLOBUS MEDICAL, INC.
6203.2100
In Commercial Distribution

  • 00193982465155 ()


  • Robotic surgical navigation system
EQ 14 PANEL DRG TEST
WAL-MART STORES, INC.
663396990
In Commercial Distribution

  • 00194346098101 ()


  • Methamphetamine-specific IVD, reagent
  • Nortriptyline IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
EQ 7 PANEL DRUG TEST
WAL-MART STORES, INC.
663495429
In Commercial Distribution

  • 00194346098095 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
KIT, DOOR PANEL - BASIC - BLK
NORTH AMERICAN RESCUE, LLC
80-1166
In Commercial Distribution

  • 00842209119141 ()
80-1166

  • First aid kit, medicated
Endeavor CR Mini Control Panel
NATUS NEUROLOGY INCORPORATED
515-013400
In Commercial Distribution

  • 00382830041621 ()


  • Electromyograph
Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control
EMG USB Control Panel II
NATUS NEUROLOGY INCORPORATED
043281
In Commercial Distribution

  • 00382830063272 ()


  • Electromyograph
BD MAX™ Vaginal Panel
BECTON, DICKINSON AND COMPANY
443712
In Commercial Distribution

  • 00382904437121 ()
443712

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
PANEL,MESH,REPLACEMENT FOR 13672,1
MEDLINE INDUSTRIES, INC.
MDT013672RM
In Commercial Distribution

  • 10888277417717 ()
MDT013672RM

  • Patient surgical drape, reusable
Ab Binder, Large (4 Panel)
PEPPER MEDICAL INC.
AB460
In Commercial Distribution

  • 00850014574581 ()
AB460

  • Abdominal binder, single-use
Ab Binder, Small (4 Panel)
PEPPER MEDICAL INC.
AB430
In Commercial Distribution

  • 00850014574567 ()
AB430

  • Abdominal binder, single-use
Ab Binder, Medium (3 Panel)
PEPPER MEDICAL INC.
AB345
In Commercial Distribution

  • 00850014574543 ()
AB345

  • Abdominal binder, single-use
Ab Binder, Small (3 Panel)
PEPPER MEDICAL INC.
AB330
In Commercial Distribution

  • 00850014574536 ()
AB330

  • Abdominal binder, single-use
POLE STAND PREC.FLAT PANEL MONITOR
PENTAX OF AMERICA, INC.
80232
In Commercial Distribution

  • 04961333241033 ()


  • Transportable medical equipment stand, non-powered
Ab Binder, Medium (4 Panel)
PEPPER MEDICAL INC.
AB445
In Commercial Distribution

  • 00850014574574 ()
AB445

  • Abdominal binder, single-use
Ab Binder, Large (3 Panel)
PEPPER MEDICAL INC.
AB360
In Commercial Distribution

  • 00850014574550 ()
AB360

  • Abdominal binder, single-use
AccuTrak T-Uptake Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0259
In Commercial Distribution

  • 00850011135815 ()


  • Multiple thyroid hormone uptake (T-uptake) IVD, control
AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
SHOWER & DISINFECTION PANEL, WHITE, US
Arjohuntleigh AB
BCA1204-04
In Commercial Distribution

  • 05055982707879 ()
BCA1204-04

  • Shower unit
AccuTrak aTSHR Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0255
In Commercial Distribution

  • 00850011135709 ()


  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
AccuTrak aTPO Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0254
In Commercial Distribution

  • 00850011135693 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
AccuTrak aTG Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0253
In Commercial Distribution

  • 00850011135686 ()


  • Thyroglobulin antibody IVD, control
AccuTrak sFlt-1 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0257
In Commercial Distribution

  • 00850011135655 ()


  • Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control
ANA Pattern Control Panel II
IMMCO DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • 00845714002168 ()

  • 5 x .5 ml
1602

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
Ready-Heat 4 Panel Heated Blanket
TECHTRADE, LLC
S4RHMD
In Commercial Distribution

  • 00850017905115 ()
  • 00850017905016 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
Ready-Heat 1 Panel Warming Wrap
TECHTRADE, LLC
S1RHSM
In Commercial Distribution

  • 00850017905139 ()
  • 00850017905009 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
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
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
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