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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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Renamel® Microhybrid - EDEL6062A31

Renamel® Microhybrid Body A3, 10 Compules
DeltaMed GmbH
6062A3
In Commercial Distribution

  • EDEL6062A30 ()
  • EDEL6062A31 ()
  • D7796062A31 ()
6062A3

  • Dental composite resin

Aqueduct SED - ACCCARTV101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101V
In Commercial Distribution

  • ACCCARTV101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCARTL200

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON200) for draining and monitoring of CSF flow from the lumbar region.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-200L
In Commercial Distribution

  • ACCCARTL200 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCART101

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-101
In Commercial Distribution

  • ACCCART101 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

Aqueduct SED - ACCCART100

The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console (ACCCON100) for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.
AQUEDUCT CRITICAL CARE, INC.
ACC-CART-100
Not in Commercial Distribution

  • ACCCART100 ()


  • Cerebrospinal fluid pressure regulation system sensor/tubing set

SmartLite Focus - D010644500701

SmartLite Focus Charging Base is a part of the SmartLite Focus Curing Light and is available separately.
Dentsply De Trey GmbH
64450070
In Commercial Distribution

  • D010644500701 ()

  • Outer Diameter: 6.5 Centimeter
64450070

  • Dental/surgical polymerization lamp

Automatrix Snippers+ Catch Tray - D010624226051

Automatrix Snippers+ Catch Tray is a part of the Automatrix Snippers+ to prevent clipped loop pieces rom the oral cavity.
Dentsply De Trey GmbH
62422605
In Commercial Distribution

  • D010624226050 ()
  • D010624226051 ()

  • Length: 1.9 Centimeter
62422605

  • Orthodontic pliers

N.A. - J011607126440

Herbst TS telescopic tube, 24 left
DENTAURUM GmbH & Co.KG
607-126-44
In Commercial Distribution

  • J011607126441 ()
  • J011607126440 ()


  • Orthodontic power arm

N.A. - J011607126340

Herbst TS telescopic tube, 24 right
DENTAURUM GmbH & Co.KG
607-126-34
In Commercial Distribution

  • J011607126341 ()
  • J011607126340 ()


  • Orthodontic power arm

N.A. - J011728507000

titanium lingual retainer, length 24 mm
DENTAURUM GmbH & Co.KG
728-507-00
Not in Commercial Distribution

  • J011728507000 ()


  • Orthodontic retainer
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