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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CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00850969007325 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00850969007929 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DR'S PANEL MOUNT, COMPACT CONTROL, 2-HANDPIECE AUTOMATIC, FOREST GREY
Ls Enterprises, Inc.
2520G
In Commercial Distribution

  • D0692520G0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2500C
In Commercial Distribution

  • D0692500C0 ()


  • Dental delivery system
REAR MOUNT LAMINATE WORKSURFACE & WALL MOUNT PANEL SIDE DELIVERY
Ls Enterprises, Inc.
3386WM
In Commercial Distribution

  • D0693386WM0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 2-HANDPIECE AUTOMATIC, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2520C
In Commercial Distribution

  • D0692520C0 ()


  • Dental delivery system
DR'S PANEL MOUNT, COMPACT CONTROL, 3-HANDPIECE AUTOMATIC, FOREST GREY
Ls Enterprises, Inc.
2500G
In Commercial Distribution

  • D0692500G0 ()


  • Dental delivery system
ATLAS Stim Headbox with Nihon Kohden passive side panel.
NEURALYNX, INC.
NK
In Commercial Distribution

  • 00867718000285 ()
31-0601-0077

  • Somatosensory electrical stimulation system
The T2Biothreat Panel component that contains the assay reagent
T2 BIOSYSTEMS, INC.
80-11394
In Commercial Distribution

  • M70880113930 ()
  • M70880113943 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BD Respiratory Viral Panel for BD MAX™ System
BECTON, DICKINSON AND COMPANY
445373
In Commercial Distribution

  • 00382904453732 ()
445373

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
MassCheck® Steroid Panel 2, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0346
In Commercial Distribution

  • 04250317533470 ()
  • 04250317545640 ()

  • 5 x 3ml
0346

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 2, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0345
In Commercial Distribution

  • 04250317533463 ()
  • 04250317545633 ()

  • 5 x 3ml
0345

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0343
In Commercial Distribution

  • 04250317533456 ()
  • 04250317545626 ()

  • 5 x 3ml
0343

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level II
Chromsystems Instruments + Chemicals GmbH
0342
In Commercial Distribution

  • 04250317533449 ()
  • 04250317545619 ()

  • 5 x 3ml
0342

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 1, Serum Control Level I
Chromsystems Instruments + Chemicals GmbH
0341
In Commercial Distribution

  • 04250317533432 ()
  • 04250317545602 ()

  • 5 x 3ml
0341

  • Multiple steroid hormone IVD, control
MassCheck® Steroid Panel 2, Serum Control Level III
Chromsystems Instruments + Chemicals GmbH
0347
In Commercial Distribution

  • 04250317533487 ()
  • 04250317545572 ()

  • 5 x 3ml
0347

  • Multiple steroid hormone IVD, control
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,XL
MEDLINE INDUSTRIES, INC.
SYN7804XL
In Commercial Distribution

  • 40888277172280 ()
  • 10888277172289 ()
SYN7804XL

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,M
MEDLINE INDUSTRIES, INC.
SYN7802M
In Commercial Distribution

  • 40888277172273 ()
  • 10888277172272 ()
SYN7802M

  • Surgical gown, reusable
EMG USB Control Panel II Kit (With USB Cable)
NATUS NEUROLOGY INCORPORATED
045108
In Commercial Distribution

  • 00382830053082 ()


  • Electromyograph
Alere Triage® 8 Panel for Drugs of Abuse
ALERE SAN DIEGO, INC.
90008
Not in Commercial Distribution

  • 00893038002098 ()
90008

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel RapidTox with THC/COC/OPI2000/AMP/BZO
AMERICAN BIO MEDICA CORPORATION
10-5ZT-200
In Commercial Distribution

  • 10694644150459 ()
  • 10694644100454 ()
10-5ZT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Panel Clia Cup COC/THC/OPI/AMP/mAMP
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-254
In Commercial Distribution

  • 00895330002806 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
6 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-FLATCUP-264
In Commercial Distribution

  • 00895330002721 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Alere Triage® Drugs of Abuse Panel Plus TCA
ALERE SAN DIEGO, INC.
92000
Not in Commercial Distribution

  • 00893038002104 ()
92000

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BINDER, ABDOMINAL, 12" 2XL (62"-75"), 4 PANEL, WHITE
Asp Global, LLC
10582XL-ASP
In Commercial Distribution

  • 00840216117587 ()


  • Abdominal binder, reusable
BINDER, ABDOMINAL, 9" 2XL (62"-75"), 3 PANEL, WHITE
Asp Global, LLC
10572XL-ASP
In Commercial Distribution

  • 00840216117570 ()


  • Abdominal binder, reusable
ALPHA MULTISTORE PANEL PC 19" TOUCH SCREEN, MEDICAL GRADE
Gimmi GmbH
S.2046.50
In Commercial Distribution

  • 04049047653509 ()
S.2046.50

  • Endoscopic video imaging system
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,XXL
MEDLINE INDUSTRIES, INC.
SYN7805XXL
In Commercial Distribution

  • 40884389172293 ()
  • 10884389172292 ()
SYN7805XXL

  • Surgical gown, reusable
PANEL 07 COC150/AMP/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020177
In Commercial Distribution

  • 10858904006355 ()
  • 00858904006358 ()
DOA-174-721

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/BZO/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020176
In Commercial Distribution

  • 10858904006348 ()
  • 00858904006341 ()
DOA-174-711

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CVi Angiographic Injection System Control Panel, p/n 701557-001
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 10841716101196 ()


  • Angiography contrast medium injection system, line-powered, mobile
I5 Printer soiled side, includes mounting panel and cables
SKYTRON LLC
I5-PRSS
In Commercial Distribution

  • 10841736100537 ()
I5-PRSS

  • Surgical instrument washer/disinfector (chemical/thermal)
I5 Printer clean side, includes mounting panel and cables
SKYTRON LLC
I5-PRCS
In Commercial Distribution

  • 10841736100513 ()
I5-PRCS

  • Surgical instrument washer/disinfector (chemical/thermal)
CVi Angiographic Injection System Control Panel, p/n 700771-005
ACIST MEDICAL SYSTEMS, INC.
017738
Not in Commercial Distribution

  • 30841716100629 ()
  • 10841716100625 ()


  • Angiography contrast medium injection system, line-powered, mobile
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,L
MEDLINE INDUSTRIES, INC.
SYN7803L
In Commercial Distribution

  • 40884389172286 ()
  • 10884389172285 ()
SYN7803L

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,S
MEDLINE INDUSTRIES, INC.
SYN7801S
In Commercial Distribution

  • 40884389172279 ()
  • 10884389172278 ()
SYN7801S

  • Surgical gown, reusable
CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
Medical Disposables Corp
M-DOA-824
In Commercial Distribution

  • 10851721007802 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 8 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-OXY-BAR-BZO-MDMA
Mlife Diagnostics, LLC
MC002.08.0001EI
In Commercial Distribution

  • G474MC002080001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC
Mlife Diagnostics, LLC
MC001.10.0001-EI
In Commercial Distribution

  • G474MC001100001EI0 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
mLife Classic 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC
Mlife Diagnostics, LLC
MC001.06.0001-EI
In Commercial Distribution

  • G474MC001060001EI0 ()


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