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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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E2 Carbon Fiber Fixed Mounting Hardware (set). Fixed mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Requires tools to remove. (Fits 3/4", 7/8" or 1" back cane diameters)
Motion Concepts Inc
CFFX
In Commercial Distribution

  • 07540147001339 ()
CFFX

  • Wheelchair back rest positioner
BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, for extraction of bony structures, in endoscopic spine surgery, Sterile, for single use
Richard Wolf GmbH
409903730US
In Commercial Distribution

  • 00814334022771 ()
  • 00814334022764 ()

  • Outer Diameter: 3 Millimeter
  • Length: 350 Millimeter
409903730US

  • Orthopaedic bur, single-use
Medical chair without wheels and not electrically powered for use of patients undergoing dental treatment or examination. Solid aluminum frame construction, easy to assemble, no tools needed. Tested to support 400 lbs (182 kg).
Safari Dentaire Inc
SAF-103-1
In Commercial Distribution

  • D104SAF1031 ()


  • General examination/treatment chair, manual
Device with hardware comprising a force plate and software for analysis of center of pressure during static and dynamic tests of stance.
EQUIDOR MEDTECH LLP
EQPOS
In Commercial Distribution

  • 08908024776005 ()


  • Posturography system
Resilient precision attachment. Kit Contains: Three Micro small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange), 2 metal jackets, 2 Alignment handles,2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool
STERNGOLD DENTAL LLC
811413
Not in Commercial Distribution

  • 00841549101830 ()


  • Resilient dental precision attachment
This part contains:Five Micro small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.
STERNGOLD DENTAL LLC
811403
Not in Commercial Distribution

  • 00841549101762 ()


  • Resilient dental precision attachment
DIAMOND BURR Ø 3MM WL 350MM ROUND PACK=5 PCS, WL 353.5mm, for use with the angled handpiece for endoscopic high-speed tools, for extraction of bony structures, in endoscopic spine surgery, Sterile, for single use
Richard Wolf GmbH
409903930US
In Commercial Distribution

  • 00814334022795 ()
  • 00814334022788 ()

  • Length: 350 Millimeter
  • Outer Diameter: 3 Millimeter
409903930US

  • Orthopaedic bur, single-use
Std. Imp. Abutment Tool Kit. Tool Kit Includes: ERA Torque Driver, ERA I/A ratchet, ERA Plastic Handles (2), ERA Core Cutter, ERA Seating tool. Includes all tools necessary to complete any standard Implant Abutment.
STERNGOLD DENTAL LLC
811908
In Commercial Distribution

  • 00841549116377 ()


  • Surgical screwdriver, reusable
Micro Imp. Abutment Tool Kit. Tool Kit Includes: Thumb Knob, ERA Socket-Micro Short, Core Cutter- Micro, Seating Tool - Micro, and Alignment Handles (2) -Micro. Includes all tools necessary to complete any Micro ERA Implant Abutment.
STERNGOLD DENTAL LLC
811907
In Commercial Distribution

  • 00841549116360 ()


  • Surgical screwdriver, reusable
Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner
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