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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MICroSTREP Plus Panel Type 2
Beckman Coulter, Inc.
B1027-202
In Commercial Distribution

  • 15099590659646 ()
  • 05099590659649 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
ESBL Plus ESBL Confirmation Panel
Beckman Coulter, Inc.
B1027-101
In Commercial Distribution

  • 15099590659608 ()
  • 05099590659601 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan Rapid Yeast ID Panel
Beckman Coulter, Inc.
B1017-70
In Commercial Distribution

  • 15099590658106 ()
  • 05099590658109 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
Neg Combo Panel Type 50
Beckman Coulter, Inc.
B1017-406
In Commercial Distribution

  • 15099590657840 ()
  • 05099590657843 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Combo Panel Type 44
Beckman Coulter, Inc.
B1017-401
In Commercial Distribution

  • 15099590657796 ()
  • 05099590657799 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Combo Panel Type 32
Beckman Coulter, Inc.
B1017-302
In Commercial Distribution

  • 15099590657642 ()
  • 05099590657645 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Combo Panel Type 31
Beckman Coulter, Inc.
B1017-301
In Commercial Distribution

  • 15099590657635 ()
  • 05099590657638 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 43
Beckman Coulter, Inc.
B1017-217
In Commercial Distribution

  • 15099590657567 ()
  • 05099590657560 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 34
Beckman Coulter, Inc.
B1017-214
In Commercial Distribution

  • 15099590657543 ()
  • 05099590657546 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos MIC Panel Type 29
Beckman Coulter, Inc.
B1017-212
In Commercial Distribution

  • 15099590657536 ()
  • 05099590657539 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos MIC Panel Type 26
Beckman Coulter, Inc.
B1017-210
In Commercial Distribution

  • 15099590657512 ()
  • 05099590657515 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 21
Beckman Coulter, Inc.
B1017-201
In Commercial Distribution

  • 15099590657383 ()
  • 05099590657386 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 20
Beckman Coulter, Inc.
B1017-200
In Commercial Distribution

  • 15099590657376 ()
  • 05099590657379 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan Rapid Anaerobe ID Panel
Beckman Coulter, Inc.
B1017-2
In Commercial Distribution

  • 15099590657352 ()
  • 05099590657355 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
Back Support, Universal Extension Panel
DEROYAL INDUSTRIES, INC.
MEP70
In Commercial Distribution

  • 00749756371919 ()
MEP70

  • Lumbar spine orthosis
DEMO TOUCH PANEL LCD 15
Smith & Nephew, Inc.
7210344Y
Not in Commercial Distribution

  • 00885556570593 ()
7210344Y

  • Image display unit, colour
Back Support Universal Extension Panel
DEROYAL INDUSTRIES, INC.
20-MEP70
In Commercial Distribution

  • 00749756376761 ()
20-MEP70

  • Lumbar spine orthosis
ANTHEM FEMORALTRIAL OUTLIER PANEL SIZE7-8
Smith & Nephew, Inc.
71442185
In Commercial Distribution

  • 00885556613474 ()
71442185

  • Instrument tray, reusable
Suntan Unit. One Panel with ten 72" suntan lamps. Panel is wall mounted.
Medtek Lighting Corporation
1000HT
In Commercial Distribution

  • B343HT1000 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 180 Pound
1000HT

  • Ultraviolet tanning device
DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-09 (US)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590733940 ()
  • 15099590733926 ()
  • 15099590733933 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
DVD, LabPro V4.42 Panel Update-08 (US); LabPro V4.42 Panel Update-08 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-08 (US)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590731151 ()
  • 15099590731144 ()
  • 15099590731168 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Dental Control Unit
Proma, Inc.
Control Unit
In Commercial Distribution

  • D142DCU01 ()


  • Dental delivery system instrument unit, pneumatic
Dental delivery system instrument unit, pneumatic
Dome, Inc.
148
In Commercial Distribution

  • D1351480 ()

  • Height: 30 Inch
148

  • Dental delivery system instrument unit, pneumatic
AS-1 Dr's wall mount delivery system
Engle Dental Systems, LLC
P070876
In Commercial Distribution

  • 00850043433378 ()
P070876

  • Dental delivery system instrument unit, pneumatic
E300 Dr's wall mount delivery system
Engle Dental Systems, LLC
P070936S
In Commercial Distribution

  • 00850043433354 ()
P070936S

  • Dental delivery system instrument unit, pneumatic
E300 Dr's post mount delivery system
Engle Dental Systems, LLC
P070935
In Commercial Distribution

  • 00850043433330 ()
P070935

  • Dental delivery system instrument unit, pneumatic
AS-1 Assistant's cart with table top
Engle Dental Systems, LLC
P050145
In Commercial Distribution

  • 00850043433132 ()
P050145

  • Dental delivery system instrument unit, pneumatic
Assistant's cart with table top
Engle Dental Systems, LLC
P050340
In Commercial Distribution

  • 00850043433118 ()
P050340

  • Dental delivery system instrument unit, pneumatic
Under cabinet mount AS-1 Delivery
Engle Dental Systems, LLC
P071964
In Commercial Distribution

  • 00850043433064 ()
P071964

  • Dental delivery system instrument unit, pneumatic
Wall mount 12 o'clock rear delivery Asst Arm Only
Engle Dental Systems, LLC
P070904
In Commercial Distribution

  • 00850043433057 ()
P070904

  • Dental delivery system instrument unit, pneumatic
Wall mount 12 o'clock rear delivery assistant's package
Engle Dental Systems, LLC
P070902
In Commercial Distribution

  • 00850043433040 ()
P070902

  • Dental delivery system instrument unit, pneumatic
Wall mount 12 o'clock rear delivery dual purpose
Engle Dental Systems, LLC
P070900
In Commercial Distribution

  • 00850043433033 ()
P070900

  • Dental delivery system instrument unit, pneumatic
Under cabinet top mount 12 o'clock rear delivery (assistant's instruments only)
Engle Dental Systems, LLC
P071460
In Commercial Distribution

  • 00850043433026 ()
P071460

  • Dental delivery system instrument unit, pneumatic
Under cabinet side mount 12 o'clock rear delivery
Engle Dental Systems, LLC
P071450
In Commercial Distribution

  • 00850043433019 ()
P071450

  • Dental delivery system instrument unit, pneumatic
Under cabinet top mount 12 o'clock rear delivery
Engle Dental Systems, LLC
P071438
In Commercial Distribution

  • 00850043433002 ()
P071438

  • Dental delivery system instrument unit, pneumatic
Under cabinet side mount 12 o'clock rear delivery (assistant's instruments only)
Engle Dental Systems, LLC
P071470
In Commercial Distribution

  • 00850043433507 ()
P071470

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible delivery system with E2 control head
Engle Dental Systems, LLC
P070941
In Commercial Distribution

  • 00850043433484 ()
P070941

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with cuspidor
Engle Dental Systems, LLC
P069240
In Commercial Distribution

  • 00850043433477 ()
P069240

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with telescopic arm
Engle Dental Systems, LLC
P069201
In Commercial Distribution

  • 00850043433460 ()
P069201

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible cuspidor with assistant's group
Engle Dental Systems, LLC
P069265
In Commercial Distribution

  • 00850043433453 ()
P069265

  • Dental delivery system instrument unit, pneumatic
Central vacuum kit, fixed position
Engle Dental Systems, LLC
P022501
In Commercial Distribution

  • 00850043433446 ()
P022501

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - long arm
Engle Dental Systems, LLC
22-507-02
In Commercial Distribution

  • 00850043433439 ()
22-507-02

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - short arm
Engle Dental Systems, LLC
22-507-01
In Commercial Distribution

  • 00850043433422 ()
22-507-01

  • Dental delivery system instrument unit, pneumatic
Cabinet vacuum group - top mount
Engle Dental Systems, LLC
22-502-02
In Commercial Distribution

  • 00850043433415 ()
22-502-02

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible assistant's group
Engle Dental Systems, LLC
P022275
In Commercial Distribution

  • 00850043433408 ()
P022275

  • Dental delivery system instrument unit, pneumatic
AS-1 Dr's wall mount delivery system
Engle Dental Systems, LLC
P070876S
In Commercial Distribution

  • 00850043433385 ()
P070876S

  • Dental delivery system instrument unit, pneumatic
AS-1 Dr's post mount delivery system
Engle Dental Systems, LLC
P070875
In Commercial Distribution

  • 00850043433361 ()
P070875

  • Dental delivery system instrument unit, pneumatic
E300 Dr's wall mount delivery system
Engle Dental Systems, LLC
P070936
In Commercial Distribution

  • 00850043433347 ()
P070936

  • Dental delivery system instrument unit, pneumatic
Utility Center Mounted AS1 Delivery Hygiene System
Engle Dental Systems, LLC
P070886
In Commercial Distribution

  • 00850043433323 ()
P070886

  • Dental delivery system instrument unit, pneumatic
Utility Center Mounted AS1 Cuspidor Delivery Hygiene System
Engle Dental Systems, LLC
P070885
In Commercial Distribution

  • 00850043433316 ()
P070885

  • Dental delivery system instrument unit, pneumatic
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