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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Reusable non-sterile tangential couchtop panel for use with Nucletron Simulix-HP
MEDTEC, INC.
MTIL3202
Not in Commercial Distribution

  • 00841439104729 ()

  • Width: 21.8 Inch
  • Length: 35.4 Inch
MTIL3202

  • Indexed-immobilization patient positioning system
For use with Varian Exact™ system
MEDTEC, INC.
MTIL3103
Not in Commercial Distribution

  • 00841439104699 ()

  • Width: 20.9 Inch
  • Length: 36.2 Inch
MTIL3103

  • Indexed-immobilization patient positioning system
Posterior panel for Varian ETR
MEDTEC, INC.
MTIL310001
Not in Commercial Distribution

  • 00841439104682 ()

  • Width: 20.9 Inch
  • Length: 47.3 Inch
MTIL310001

  • Indexed-immobilization patient positioning system
No Description
Aktina Corp.
51-220
In Commercial Distribution

  • B365512200 ()


  • Indexed-immobilization patient positioning system
No Description
Bracco Injeneering SA
017382
In Commercial Distribution

  • 37630039300419 ()
017382

  • MRI contrast medium injection system, line-powered, mobile
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801083 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Remote Start/Stop
Breas Medical AB
006649
In Commercial Distribution

  • 07321820066490 ()
006649

  • Assistive remote control
Remote Start/Stop
Breas Medical AB
006342
In Commercial Distribution

  • 07321820063420 ()
006342

  • Assistive remote control
No Description
EITAN MEDICAL LTD
15071-000-0005
Not in Commercial Distribution

  • 07290109150031 ()
  • 27290109150035 ()
  • 17290109150038 ()
15071-000-0005

  • Assistive remote control
No Description
LivaNova Deutschland GmbH
System Panel
In Commercial Distribution

  • 04033817901433 ()


  • Cardiopulmonary bypass system, roller type
NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices.
Circassia AB
Apps / Panel
In Commercial Distribution

  • 07350047030519 ()
12-1004

  • Patient health record information system application software
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Smart Control Panel
MEDICAPTURE, INC.
MSP156
In Commercial Distribution

  • 00859151005293 ()
MSP156

  • Medical video image recorder
1-mode small panel
Biophotas, Inc.
CLEAR C/US
In Commercial Distribution

  • 00850523007037 ()
CLTC-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
Biophotas, Inc.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
Biophotas, Inc.
SKIN C/US
In Commercial Distribution

  • 00850523007600 ()
CSKN-001

  • Blue/red/infrared phototherapy lamp
E600 Built-In Panel
Beyes Dental Canada Inc
MT600TP
In Commercial Distribution

  • 00990010301771 ()
M600

  • Dental surgical power tool motorized handpiece/set, electric
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-3867
In Commercial Distribution

  • 00898142001944 ()
16-1P3-3867

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-9013
In Commercial Distribution

  • 00898142001746 ()
16-1P3-9013

  • Cranioplasty sheet
Hex Panel, 0.2mm
Kinamed, Inc.
16-1P3-4066
In Commercial Distribution

  • 00898142001739 ()
16-1P3-4066

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
16-1P3-8913
In Commercial Distribution

  • 00898142001692 ()
16-1P3-8913

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
14-1P3-8620
In Commercial Distribution

  • 00898142001166 ()
14-1P3-8620

  • Cranioplasty sheet
Plate Panel, 0.4mm
Kinamed, Inc.
14-1P3-8613
In Commercial Distribution

  • 00898142001135 ()
14-1P3-8613

  • Cranioplasty sheet
E600 Built-In Panel
Beyes Dental Canada Inc
MT600TP
In Commercial Distribution

  • 00837699000581 ()


  • Dental surgical power tool motorized handpiece/set, electric
Top Panel, Beige
SAKURA FINETEK U.S.A., INC.
4013
In Commercial Distribution

  • 08720177655620 ()
4013

  • Microscope slide cabinet
Top Panel, Green
SAKURA FINETEK U.S.A., INC.
4012
In Commercial Distribution

  • 08720177655613 ()
4012

  • Microscope slide cabinet
PANEL 1 PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020021
In Commercial Distribution

  • 10858904006089 ()
  • 00858904006082 ()
DPC-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 M-AMP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020002
In Commercial Distribution

  • 10858904006126 ()
  • 00858904006129 ()
DMA-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 1 THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020004
In Commercial Distribution

  • 10858904006102 ()
  • 00858904006105 ()
DTH-114-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Control Panel Unit
NIHON KOHDEN AMERICA, INC.
PV-230B
In Commercial Distribution

  • 00841983101090 ()
PV-230B

  • Evoked-potential graphic recording system
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