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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Sona-Speech II
PENTAX OF AMERICA, INC.
3650
In Commercial Distribution

  • 04961333229635 ()
N/A

  • Electroglottograph
Auditory Feedback Tools, Software
PENTAX OF AMERICA, INC.
3506
In Commercial Distribution

  • 04961333229628 ()
N/A

  • Electroglottograph
EPK-1000 VIDEO PROCESSOR (US NEW)
PENTAX OF AMERICA, INC.
EPK-1000-US
In Commercial Distribution

  • 04961333228928 ()


  • Endoscopic video image processing unit
VIDEO COLONOSCOPE
PENTAX OF AMERICA, INC.
EC38-I10NF
In Commercial Distribution

  • 04961333225613 ()


  • Flexible video colonoscope, reusable
DEFINA HD VIDEO PROCESSOR (US NEW)
PENTAX OF AMERICA, INC.
EPK-3000-US
In Commercial Distribution

  • 04961333225262 ()


  • Endoscopic video image processing unit
Smart Laser DP
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-100
In Commercial Distribution

  • 00859626006343 ()
ML-830-07-100

  • Musculoskeletal/physical therapy laser, home-use
Laser Probe Cover
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-005
In Commercial Distribution

  • 00859626006336 ()
  • 00859626006060 ()
ML-830-01-005

  • Optical medical device procedural cover
SL Triple Probe Holder
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-007
In Commercial Distribution

  • 00859626006312 ()
ML-830-07-007

  • Laser beam delivery unit holder
SL Power Supply
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-004
In Commercial Distribution

  • 00859626006299 ()
ML-830-07-004

  • Noninvasive device battery charger
SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution

  • 00859626006282 ()
ML-830-07-003

  • Laser application software
SL Single Probe
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-002
In Commercial Distribution

  • 00859626006275 ()
ML-830-07-002

  • Musculoskeletal/physical therapy laser, home-use
SL Triple Probe
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-001
In Commercial Distribution

  • 00859626006268 ()
ML-830-07-001

  • Musculoskeletal/physical therapy laser, home-use
Smart Laser
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-000
In Commercial Distribution

  • 00859626006251 ()
ML-830-07-000

  • Musculoskeletal/physical therapy laser, home-use
DC Accessory Set
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-011
In Commercial Distribution

  • 00859626006237 ()
ML-830-02-011

  • Laser adaptor
DC Console Base
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-009
In Commercial Distribution

  • 00859626006213 ()
ML-830-04-009

  • Basic power supply, reusable
DC Console Adapter with Cord
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-003
In Commercial Distribution

  • 00859626006206 ()
ML-830-04-003

  • Laser adaptor
DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application software
New Direct Connect Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-000
In Commercial Distribution

  • 00859626006183 ()
ML-830-04-000

  • Musculoskeletal/physical therapy laser, home-use
Conversion Probe
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-010
In Commercial Distribution

  • 00859626006176 ()
ML-830-02-010

  • Musculoskeletal/physical therapy laser, home-use
Refurbished Screw-On Adapter
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-007
In Commercial Distribution

  • 00859626006152 ()
ML-830-02-007

  • Laser adaptor
Screw-On Adapter - green LED
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-006
In Commercial Distribution

  • 00859626006145 ()
ML-830-02-006

  • Laser adaptor
Screw-On Adapter - beeping
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-005
In Commercial Distribution

  • 00859626006138 ()
ML-830-02-005

  • Laser adaptor
Transformer with Output Cord
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-004
In Commercial Distribution

  • 00859626006121 ()
ML-830-02-004

  • Isolation transformer
Small Danger Sign
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-003
In Commercial Distribution

  • 00859626006114 ()
ML-830-02-003

  • Safety sign
Original Direct Connect
MICROLIGHT CORPORATION OF AMERICA
ML-830-02-000
In Commercial Distribution

  • 00859626006107 ()
ML-830-02-000

  • Musculoskeletal/physical therapy laser, home-use
Line Cord
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-013
In Commercial Distribution

  • 00859626006091 ()
ML-830-01-013

  • Electrical mains power cable
Large Danger Sign
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-009
In Commercial Distribution

  • 00859626006077 ()
ML-830-01-009

  • Safety sign
Safety Glasses
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-007
In Commercial Distribution

  • 00859626006053 ()
ML-830-01-007

  • Radiation shielding goggles
Laser Probe
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-004
In Commercial Distribution

  • 00859626006046 ()
ML-830-01-004

  • Musculoskeletal/physical therapy laser, home-use
Refurbished Battery (rechargeable)
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-003
In Commercial Distribution

  • 00859626006039 ()
ML-830-01-003

  • Portable/mobile rechargeable battery pack
Battery (rechargeable)
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-002
In Commercial Distribution

  • 00859626006022 ()
ML-830-01-002

  • Portable/mobile rechargeable battery pack
Charging Station
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-001
In Commercial Distribution

  • 00859626006015 ()
ML-830-01-001

  • Noninvasive device battery charger
Battery Unit
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-000
In Commercial Distribution

  • 00859626006008 ()
ML-830-01-000

  • Musculoskeletal/physical therapy laser, home-use
No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution

  • 00869202000214 ()


  • Blood bank information system application software
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE
Fruit of the Loom
PI.421EGHT.O6J.L.0.0
Not in Commercial Distribution

  • 10194422108271 ()
  • 00194422108274 ()
  • 20194422108278 ()


  • Isolation gown, single-use
100% POLYPROPYLENE NON-SURGICAL PROTECTIOVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE
Fruit of the Loom
PI.421EGHT.O6J.XL.0.0
Not in Commercial Distribution

  • 10194422108264 ()
  • 00194422108267 ()
  • 20194422108261 ()


  • Isolation gown, single-use
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, CLOSED BACK, SINGLE USE
Fruit of the Loom
PI.421EGHT.O6J.2X.0.0
Not in Commercial Distribution

  • 10194422108257 ()
  • 00194422108250 ()
  • 20194422108254 ()


  • Isolation gown, single-use
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK, NOT PROTECTED, SINGLE USE
Fruit of the Loom
PI.408EGHT.O6J.L.0.0
Not in Commercial Distribution

  • 10194422075542 ()
  • 00194422075545 ()
  • 20194422075549 ()

  • LARGE


  • Isolation gown, single-use
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK,NOT PROTECTED, SINGLE USE
Fruit of the Loom
PI.408EGHT.O6J.2X.0.0
Not in Commercial Distribution

  • 10194422075535 ()
  • 00194422075538 ()
  • 20194422075532 ()

  • EXTRA EXTRA LARGE


  • Isolation gown, single-use
100% POLYPROPYLENE NON-SURGICAL PROTECTIVE GOWN, OVER THE HEAD, AAMI LEVEL 2 MEDICAL, NON-SURGICAL, DISPOSABLE, OPEN BACK, NOT PROTECTED, SINGLE USE
Fruit of the Loom
PI.408EGHT.O6J.XL.0.0
Not in Commercial Distribution

  • 10194422075528 ()
  • 00194422075521 ()
  • 20194422075525 ()

  • EXTRA LARGE


  • Isolation gown, single-use
Get sensitivity relief + whitening all in one mint toothpaste for your oral care routine. The amino acid arginine + calcium carbonate complex contains arginine to deliver sensitivity relief within 60 seconds.This natural formula provides 24/7 protection for sensitive teeth and safely whitens your teeth.
TOM'S OF MAINE, INC.
61016024
In Commercial Distribution

  • 10035000992977 ()
  • 20035000992974 ()
  • 00035000992970 ()


  • Dental cavity varnish
Tom's of Maine Rapid Relief Sensitive Toothpaste for sensitive teeth. Clinically Proven Formula with Arginine & Calcium Carbonate. Seals exposed pathways to the nerve for Rapid Relief & Long-Lasting Protection.
TOM'S OF MAINE, INC.
683562
In Commercial Distribution

  • 20077326835627 ()
  • 10077326835620 ()
  • 00077326835623 ()


  • Dental cavity varnish
PHONATORY AERODYNAMIC SYSTEM
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333247424 ()


  • Speech assistive training device
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333247417 ()


  • Speech assistive training device
Light Cable3.5 X 2300
PENTAX OF AMERICA, INC.
8870
In Commercial Distribution

  • 04961333230235 ()

  • Length: 2300 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Rigid optical nasopharyngoscope
CBL,4 FIBER LC-LC 75FT
PENTAX OF AMERICA, INC.
92200/75
In Commercial Distribution

  • 04961333242573 ()

  • Length: 75.0 Feet


  • Radiology information system
STANDARD CART
PENTAX OF AMERICA, INC.
80247
In Commercial Distribution

  • 04961333241118 ()

  • Depth: 30.0 Inch
  • Width: 24.5 Inch
  • Height: 61.0 Inch


  • Endoscope transport trolley
POWER SUPPLY -NDS 32" SPLIT SCREEN MON.
PENTAX OF AMERICA, INC.
M34021
In Commercial Distribution

  • 04961333243457 ()

  • Length: 32.0 Inch


  • Electrical mains power extension cable
6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600)
PENTAX OF AMERICA, INC.
6650
In Commercial Distribution

  • 04961333255986 ()


  • Speech assistive training device
6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600)
PENTAX OF AMERICA, INC.
6651
In Commercial Distribution

  • 04961333255979 ()


  • Speech assistive training device
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