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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Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. 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 Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution

  • 00850011150061 ()
10000041

  • Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
No Description
FLEXICARE MEDICAL LIMITED
035-55-210GU
In Commercial Distribution

  • 05055788753926 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-210SU
In Commercial Distribution

  • 05055788753902 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-220SU
In Commercial Distribution

  • 05055788753865 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-220VU
In Commercial Distribution

  • 05055788753834 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-230MU
In Commercial Distribution

  • 05055788753803 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-230VU
In Commercial Distribution

  • 05055788753773 ()


  • Anaesthesia face mask, single-use
Stop scews, inner ø 1.15 mm/45
DENTAURUM GmbH & Co.KG
480-918-02
In Commercial Distribution

  • J011480918020 ()
  • J011480918021 ()


  • Orthodontic tube
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution

  • 04068151009477 ()


  • PET system application software
  • SPECT system application software
The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter’s main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).
HAN CHANG CO., LTD
SpineKure Kyphoplasty System
In Commercial Distribution

  • 08809300542973 ()


  • Balloon kyphoplasty kit
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