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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Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 pouches per box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771052856 ()
  • 10849771052859 ()
  • 00849771052852 ()
  • 00849771033493 ()
SL204

  • Procedural medication labelling set
Sterile Labels - Sterile Labels - Custom, 10 labels per panel, 2 panels per pouch, 100 packages per box
KEY SURGICAL, INC.
SL201
In Commercial Distribution

  • 20849771052849 ()
  • 10849771052842 ()
  • 00849771052845 ()
  • 00849771033462 ()
SL201

  • Procedural medication labelling set
mLife Verify 9 Panel Oral Fluid Drug Test AMP BAR BZO COC MDMA MET MTD OPI OXY
Mlife Diagnostics, LLC
MV002.09.0004EI
In Commercial Distribution

  • G474MV002090004EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QC Sets and Panels: Helix Elite™ Molecular Standards Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
MICROBIOLOGICS INC.
8250
In Commercial Distribution

  • 70845357043749 ()
8250

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8229
In Commercial Distribution

  • 70845357042728 ()
8229

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
IDUN SOLUTIONS LLC
12511105000034
In Commercial Distribution

  • 90857275007813 ()


  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose®, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413518
In Commercial Distribution

  • 10768455130204 ()
  • 00768455130207 ()
  • 00768455187782 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (40/50Mm)
CONVATEC, PURCHASING DEPARTMENT
413517
In Commercial Distribution

  • 10768455130198 ()
  • 00768455130191 ()
  • 00768455187775 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413516
In Commercial Distribution

  • 10768455130181 ()
  • 00768455130184 ()
  • 00768455187768 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, One-Sided Comfort Panel 12" Transparent, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413515
In Commercial Distribution

  • 10768455130174 ()
  • 00768455130177 ()
  • 00768455187751 ()


  • One-piece intestinal ostomy bag, open-ended
Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (30/40Mm)
CONVATEC, PURCHASING DEPARTMENT
413510
In Commercial Distribution

  • 10768455130068 ()
  • 00768455130061 ()
  • 00768455187737 ()


  • One-piece intestinal ostomy bag, closed-ended
Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (20/30Mm)
CONVATEC, PURCHASING DEPARTMENT
413509
In Commercial Distribution

  • 10768455130051 ()
  • 00768455130054 ()
  • 00768455187720 ()


  • One-piece intestinal ostomy bag, closed-ended
SUR-FIT Natura® Little Ones® Urostomy Pouch W/1 Sided Comfort Panel, Transparent 1 1/4"
CONVATEC, PURCHASING DEPARTMENT
401929
In Commercial Distribution

  • 10768455104168 ()
  • 00768455104161 ()
  • 00768455183265 ()


  • Multiple-piece urostomy bag, open-ended
5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004005
In Commercial Distribution

  • 06977469280004 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004001
In Commercial Distribution

  • 06977469280011 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-20124
In Commercial Distribution

  • 20817038021099 ()
  • 10817038021092 ()
  • 00817038021095 ()
U-CUP-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-DOA-3124
In Commercial Distribution

  • 20817038020498 ()
  • 10817038020491 ()
  • 00817038020494 ()
U-DOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-6-60669
In Commercial Distribution

  • 00816610020914 ()
CLIA-IDTC-6-60669

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Right Small
In Commercial Distribution

  • 00810113680316 ()
EZA71RS

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Right Medium
In Commercial Distribution

  • 00810113680309 ()
EZA71RM

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Right Large
In Commercial Distribution

  • 00810113680293 ()
EZA71RL

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Left Small
In Commercial Distribution

  • 00810113680286 ()
EZA71LS

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Left Medium
In Commercial Distribution

  • 00810113680279 ()
EZA71LM

  • Ankle/foot orthosis
This a low profile, rigid, and quick application AFO. The brace has a detachable posterior panel and limited SKUs. A great step up from a simple figure eight ankle brace. Low profile Rigid ankle Detachable posterior panel
Manamed, Inc.
ManaEZ Ankle 71 Left Large
In Commercial Distribution

  • 00810113680262 ()
EZA71LL

  • Ankle/foot orthosis
Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX2
In Commercial Distribution

  • 08809460309867 ()
IOX2

  • Dental digital imaging sensor, intraoral
Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Dentium Co., Ltd
IOX1
In Commercial Distribution

  • 08809460309850 ()
IOX1

  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR
SIRONA DENTAL, INC.
B1316200
In Commercial Distribution

  • D764B13162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR
SIRONA DENTAL, INC.
B1216200
In Commercial Distribution

  • D764B12162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR
SIRONA DENTAL, INC.
B1116200
In Commercial Distribution

  • D764B11162000 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005574
In Commercial Distribution

  • D7641000055741 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005572
In Commercial Distribution

  • D7641000055721 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005571
In Commercial Distribution

  • D7641000055711 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005570
In Commercial Distribution

  • D7641000055701 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005566
In Commercial Distribution

  • D7641000055661 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005565
In Commercial Distribution

  • D7641000055651 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005420
In Commercial Distribution

  • D7641000054201 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005419
In Commercial Distribution

  • D7641000054191 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005418
In Commercial Distribution

  • D7641000054181 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005412
In Commercial Distribution

  • D7641000054121 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005411
In Commercial Distribution

  • D7641000054111 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005410
In Commercial Distribution

  • D7641000054101 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
SIRONA DENTAL, INC.
100005393
In Commercial Distribution

  • D7641000053931 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
SIRONA DENTAL, INC.
100005392
In Commercial Distribution

  • D7641000053921 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005391
In Commercial Distribution

  • D7641000053911 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005575
In Commercial Distribution

  • D7641000055751 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S1 SENSOR BASIC KIT, .9M/3FT
SIRONA DENTAL, INC.
100005573
In Commercial Distribution

  • D7641000055731 ()


  • Dental digital imaging sensor, intraoral
FONA STELLARIS S0 SENSOR BASIC KIT, 1.8M/6FT
SIRONA DENTAL, INC.
100005567
In Commercial Distribution

  • D7641000055671 ()


  • Dental digital imaging sensor, intraoral
No Description
DIASORIN MOLECULAR LLC
MOL2655
In Commercial Distribution

  • 20816101026962 ()
MOL2655

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Image-intensified fluoroscopic x-ray system, mobile
Ziehm-Orthoscan, Inc.
1000-0004-FD
In Commercial Distribution

  • B22510000004FD0 ()


  • Portable general-purpose fluoroscopic x-ray system, digital
Lyra RSV+HMPV Assay
DIAGNOSTIC HYBRIDS, INC.
M103
In Commercial Distribution

  • 30014613311034 ()
M103

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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