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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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Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Syringe. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 70-12 N
In Commercial Distribution

  • D801SP7012N1 ()
70-12

  • Dental etching solution
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Syringe. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 70-12 B
In Commercial Distribution

  • D801SP7012B1 ()
70-12

  • Dental etching solution
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software
The inductive charger JMA-Optic is an accessory of the facebow JMA-Optic and intended for wireless charging of the facebow batteries.
zebris MEDICAL GmbH
01570510
In Commercial Distribution

  • B915015705101 ()
NA

  • Facebow
MDI 2.5 -US is a mini dental implant site preparation insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
MDI 2.5 -US
In Commercial Distribution

  • E322035100141010 ()
03510014-101

  • Dental ultrasonic surgical system handpiece tip
MDI 2.2 -US is a mini dental implant site preparation insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
MDI 2.2 -US
In Commercial Distribution

  • E322035100131010 ()
03510013-101

  • Dental ultrasonic surgical system handpiece tip
MDI 1.9 -US is a mini dental implant site preparation insert to be used in conjunction with Mectron Piezosurgery handpieces.
MECTRON SPA
MDI 1.9 -US
In Commercial Distribution

  • E322035100121010 ()
03510012-101

  • Dental ultrasonic surgical system handpiece tip
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
19 FLEXIBLE channels
In Commercial Distribution

  • EBCI5730PRO0 ()
5730PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8 FLEXIBLE channels
In Commercial Distribution

  • EBCI5720PRO0 ()
5720PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16 FLEXIBLE channels
In Commercial Distribution

  • EBCI5710PRO0 ()
5710PRO

  • Multiple physiological signal amplifier
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