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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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AdvanSync 2 - 00889989054712

CROWN W/CUTOUT-ADVANSYNC 2 U6L SIZE 5 PK5
ORMCO CORPORATION
600-4305
In Commercial Distribution

  • 20889989054716 ()
  • 00889989054712 ()

  • Band Size 5


  • Orthodontic metal band

Solitaire 2 - 00836462016408

SFR2-6-30 SOLITAIRE 2 DEVICE
Micro Therapeutics, Inc.
SFR2-6-30
In Commercial Distribution

  • 00836462016408 ()

  • Length: 42 Millimeter
  • Outer Diameter: 6 Millimeter
  • Usable Length,30,Millimeter;Push Wire Length,180,Centimeter;


  • Thrombectomy suction catheter

Sepax 2 - 07640125650587

No Description
Biosafe S.A.
Sepax 2 S-100
In Commercial Distribution

  • 07640125650587 ()
14000

  • Blood centrifugation system processing unit

Primescan 2 - E27668356100

Primescan 2 Spare
SIRONA Dental Systems GmbH
6835610
In Commercial Distribution

  • E27668356100 ()
6835610

  • Intraoral optical scanning system

Primescan 2 - E27668310150

Primescan 2
SIRONA Dental Systems GmbH
6831015
In Commercial Distribution

  • E27668310150 ()


  • Intraoral optical scanning system

Primescan 2 - E27668186992

Single use sleeve Primescan 2 Box
SIRONA Dental Systems GmbH
6818699
In Commercial Distribution

  • E27668127750 ()
  • E27668186992 ()


  • Intraoral optical scanning system

Primescan 2 - E27668020400

Primescan 2
SIRONA Dental Systems GmbH
6802040
In Commercial Distribution

  • E27668020400 ()
6802040

  • Intraoral optical scanning system

Primescan 2 - E2766802040

Primescan 2
SIRONA Dental Systems GmbH
6802040
Not in Commercial Distribution

  • E2766802040 ()
6802040

  • Intraoral optical scanning system

Hi-Rem+ # 2 - 08059388441679

No Description
OVERFIBERS SRL
Hi-Rem+ # 2
In Commercial Distribution

  • 08059388443284 ()
  • 08059388441679 ()
RHP602

  • Root canal post, preformed

LUMIX 2 - 08057949170020

LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170020 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC02

  • Skin laser scanner

LUMIX 2 - 08057949170013

LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170013 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC01

  • Skin laser scanner

T-Mic 2 - 00840094452565

Large
Advanced Bionics, LLC
CI-5835-300
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor

T-Mic 2 - 00840094452558

Medium
Advanced Bionics, LLC
CI-5835-200
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor

T-Mic 2 - 00840094452541

Small
Advanced Bionics, LLC
CI-5835-100
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor

ScripHessco 2" - 00092237900536

Basic 2" Round Cloth
COMPASS HEALTH BRANDS CORP.
672 0192
In Commercial Distribution

  • 80092237900532 ()
  • 30092237900537 ()
  • 00092237900536 ()
  • 01092237900535 ()


  • Transcutaneous electrical stimulation electrode, single-use

TalkingBrix 2 - 00186648000524

Expand your communication options with a set of three TalkingBrix 2 speech devices. Pressing the colored top plays a single message up to 10-seconds long. Use individually or connect to make a multi-message speech device. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Add strategically around the classroom or home to provide on-the-spot communication Use together to make choices Use with multiple individuals at one time to provide each with a unique communication message Features High-quality sound suitable for almost any environment Long-lasting rechargeable battery Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the TalkingBrix2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000032
In Commercial Distribution

  • 00186648000524 ()
10000032

  • Assistive speech generator

Genius 2 - 00884838030497

No Description
Philips Medical Systems Hsg
989803180831
Not in Commercial Distribution

  • 00884838030497 ()
989803180831

  • Electrocardiographic lead set, reusable

Autoject 2 - 15016189106015

1ml glass syringe, non-sterile reusable injector.
OWEN MUMFORD LIMITED
AJ1060
In Commercial Distribution

  • 15016189106015 ()
  • 25016189106012 ()

  • Width: 25 Millimeter
  • Length: 190 Millimeter
AJ1060

  • Syringe-loaded medication/vaccine injector, manual, professional

Bio.N.2 - 14897076722577

No Description
TENS PLUS INDUSTRIAL COMPANY
MD2863
In Commercial Distribution

  • 14897076722577 ()


  • Static magnetic massager

Harmony 2 - D7076436110

No Description
IVOCLAR VIVADENT, INC.
643611
Not in Commercial Distribution

  • D7076436110 ()
643611

  • Dental casting noble alloy
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