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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NON BRANDED VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036940 ()
1036946

  • Computed radiography digital imaging scanner
VITA XE CR SYSTEM
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971036933 ()
1036938

  • Computed radiography digital imaging scanner
Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
CR MD4.0 GENERAL PLATE 14X51I.
AGFA
CR MD4.0 GENERAL PLATE 14X51
In Commercial Distribution

  • 05414904044100 ()

  • Width: 51 Inch
  • Length: 14 Inch
5O6MS

  • Digital imaging storage phosphor screen
CR MD4.0 GENERAL CASS HR 8X10I
AGFA
CR MD4.0 GENERAL CASSETTE 8x10
In Commercial Distribution

  • 05414904028971 ()

  • Width: 10 Inch
  • Length: 8 Inch
37PQH

  • Digital imaging cassette
3 Panel One Step DOA Cup(3.36) - COC300 AMP1000 MET1000
BTNX Inc
D3.36-1V
In Commercial Distribution

  • 00722066005309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch
GENMARK DIAGNOSTICS, INC.
BCID-GP Cartridge Pouch
In Commercial Distribution

  • 00857167005337 ()
KT021791

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box
GENMARK DIAGNOSTICS, INC.
BCID-GP 12 Kit Box
In Commercial Distribution

  • 00857167005320 ()
EA003012

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
3B Medical, Inc. filter replacements for cabinent and panel filters
3B MEDICAL, INC.
CIR1020 CIR1030
In Commercial Distribution

  • 00853041003819 ()


  • Stationary oxygen concentrator
Single Panel Pre Screen Plus Dip Card Drug Combo: THC
MERGERS MARKETING, INC.
PS-THC-114
In Commercial Distribution

  • 10850557007413 ()
  • 00850557007409 ()
  • 00850557007416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: BUP
MERGERS MARKETING, INC.
PS-BUP-114
In Commercial Distribution

  • 00850557007003 ()
  • 00850557007010 ()
  • 10850557007017 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: OXY
MERGERS MARKETING, INC.
PS-OXY
In Commercial Distribution

  • 00851000007274 ()
  • 00851000007267 ()
  • 00851000007250 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Pre Screen Plus Dip Card Drug Combo: ETG
MERGERS MARKETING, INC.
PS-ETG
In Commercial Distribution

  • 10851000007097 ()
  • 00851000007090 ()
  • 00851000007083 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen™ RAPID DRUG TEST CUP, 14 Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-14CLIA
In Commercial Distribution

  • 30850054867941 ()
  • 00850054867940 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
LED Body Panel- Boost Branded- (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN19I
In Commercial Distribution

  • 05060534510364 ()
145A

  • Cosmetic red-light phototherapy system, home-use
BINDER, ABDOMINAL, 12" LG/XL (46"-62"), 4 PANEL, WHITE
Asp Global, LLC
1058LXL-ASP
In Commercial Distribution

  • 00840216117594 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 12" S/M (30"-45"), 4 PANEL, WHITE
Asp Global, LLC
1058SM-ASP
In Commercial Distribution

  • 00840216117563 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" LG/XL (46"-62"), 3 PANEL, WHITE
Asp Global, LLC
1057LXL-ASP
In Commercial Distribution

  • 00840216117556 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" S/M (30"-45"), 3 PANEL, WHITE
Asp Global, LLC
1057SM-ASP
In Commercial Distribution

  • 00840216117549 ()


  • Abdominal binder, reusable
Sony Medical Grade Flat Panel Monitor, HD, without stand, 24"
BR Surgical, LLC
BR900-4424
In Commercial Distribution

  • 00840183514006 ()
BR900-4424

  • Image display unit, colour
5 Panel Drug Test Cup AMP/COC/OPI/THC/PCP
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038022287 ()
  • 10817038022280 ()
  • 00817038022283 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/OPI/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038021273 ()
  • 10817038021276 ()
  • 00817038021279 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup mAMP-COC-THC/MOP-MDMA-MTD/BAR-BZO-PCP/AMP-OXY/BUP
UCP BIOSCIENCES, INC.
U-CUP-8124
In Commercial Distribution

  • 20817038020542 ()
  • 10817038020545 ()
  • 00817038020548 ()
U-CUP-8124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen AMP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-AMP-114L
In Commercial Distribution

  • 20817038021877 ()
  • 10817038021870 ()
  • 00817038021873 ()
U-AMP-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen MOP Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-MOP-114L
In Commercial Distribution

  • 20817038021846 ()
  • 10817038021849 ()
  • 00817038021842 ()
U-MOP-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114L
In Commercial Distribution

  • 20817038021839 ()
  • 10817038021832 ()
  • 00817038021835 ()
U-OXY-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen Opiates Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OPI-114L
In Commercial Distribution

  • 20817038021822 ()
  • 10817038021825 ()
  • 00817038021828 ()
U-OPI-114L

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
6 panel Test Card AMP/BZO/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-264L
In Commercial Distribution

  • 20817038021150 ()
  • 10817038021153 ()
  • 00817038021156 ()
U-DOA-264L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-CUP-254
In Commercial Distribution

  • 20817038021112 ()
  • 10817038021115 ()
  • 00817038021118 ()
U-CUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
90cm single pivot 7 panel under table shield low profile
AADCO MEDICAL, INC.
S-315
In Commercial Distribution

  • 00840348508772 ()
S-315

  • Radiation shielding table drape
MRI-SAFE UNDER-TBL MTD RAD SHIELD 70CMX90CM WIDE W/TOP PANEL
AADCO MEDICAL, INC.
S-314NF
In Commercial Distribution

  • 00840348508758 ()
S-314NF

  • Radiation shielding table drape
I3 Service door with Printer; includes mounting panel and cables
SKYTRON LLC
I3-PR
In Commercial Distribution

  • 10841736100353 ()
I3-PR

  • Surgical instrument washer/disinfector (chemical/thermal)
MassCheck® Steroid Panel 1&2, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0340
In Commercial Distribution

  • 04250317539823 ()
  • 04250317546708 ()

  • 5 x 3ml
0340

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1&2, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0339
In Commercial Distribution

  • 04250317539816 ()
  • 04250317546692 ()

  • 5 x 3ml
0339

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1&2, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0338
In Commercial Distribution

  • 04250317539809 ()
  • 04250317546685 ()

  • 5 x 3ml
0338

  • Multiple steroid hormone IVD, control
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2186G
In Commercial Distribution

  • D0692186G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, UNDER WORKSURFACE PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2186C
In Commercial Distribution

  • D0692186C0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2184G
In Commercial Distribution

  • D0692184G0 ()


  • Dental delivery system
DUO UNIT, LEFT/RIGHT, VERTICAL MOUNT PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2184C
In Commercial Distribution

  • D0692184C0 ()


  • Dental delivery system
4 Panel Home Drug Test Kit THC COC OPI MET
CONFIRM BIOSCIENCES, INC.
RO-DRC004
In Commercial Distribution

  • 00895330002370 ()


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