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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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Celebrity XL 4 Wheel - 00606509300070

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4450/SC4450/Elegance Plus
In Commercial Distribution

  • 00606509300070 ()
N/A

  • Assistive scooter, electric-motor-driven

Jazzy ZTS - 00606509300056

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
Jazzy Zero Turn Scooter
In Commercial Distribution

  • 00606509300056 ()
N/A

  • Assistive scooter, electric-motor-driven

Celebrity DX 4 Wheel - 00606509300032

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC4401DX/S4401DX/Celebrity DXL/Celebrity Sport 4 Wheel/S4401DXSP
In Commercial Distribution

  • 00606509300032 ()
N/A

  • Assistive scooter, electric-motor-driven

Celebrity X 4 Wheel - 00606509300018

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4401/SC4401
In Commercial Distribution

  • 00606509300018 ()
N/A

  • Assistive scooter, electric-motor-driven

PABLO - 09120077180151

PABLO is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180151 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

Excel - D798ERJB0

Excel is intended for use as an orthodontic bonding adhesive for appliances. This is a12g Excel Regular Adhesive paste B in a jar.
RELIANCE ORTHODONTIC PRODUCTS INC
ERJB
In Commercial Distribution

  • D798ERJB0 ()
ERJB

  • Orthodontic bracket adhesive

BandLok - D798BLSAB0

BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of BandLok Part A, Blue Shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSAB
In Commercial Distribution

  • D798BLSAB0 ()
BLSAB

  • Orthodontic bracket adhesive

Ortho FlexTech - D798SSOFTSAMETCHED0

Stainless Steel Ortho FlexTech Dental Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel Etched version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFTSAMETCHED
In Commercial Distribution

  • D798SSOFTSAMETCHED0 ()
SSOFTSAMETCHED

  • Orthodontic retainer

Ortho FlexTech - D798SSOFTE0

Stainless Steel Ortho FlexTech Dental Retention System is intended for use as a Lingual Retainer Wire. This is the Stainless Steel Etched version.
RELIANCE ORTHODONTIC PRODUCTS INC
SSOFTE
In Commercial Distribution

  • D798SSOFTE0 ()
SSOFTE

  • Orthodontic retainer

EZCare™ Softouch - 10812594012829

The EZCare Softouch is intended to secure a patient’s tracheostomy tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Medium Tan
In Commercial Distribution

  • 00812594012822 ()
  • 10812594012829 ()
N925

  • Tracheostomy tube neck holder, single-use
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