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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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ATOZ Expander Kit *10SET
MK Meditech Inc.
ATOZ Expander Kit*10SET
In Commercial Distribution

  • 08800197900075 ()


  • Orthodontic palate expander screw key
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic anchoring screw
  • Orthodontic archwire
  • Surgical screwdriver, reusable
The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*2ea, MKS-1613*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea
MK Meditech Inc.
ATOZ Expander Kit
In Commercial Distribution

  • 08800197900068 ()


  • Surgical screwdriver, reusable
  • Orthodontic archwire
  • Orthodontic anchoring screw
  • Orthodontic palate expander/teeth aligner, bonded
  • Orthodontic palate expander screw key
Griplasty System - Base of Thumb with Needles
FIELD ORTHOPAEDICS PTY LTD
1
In Commercial Distribution

  • 09353903030003 ()
GPBOTN

  • Tendon/ligament bone anchor, non-bioabsorbable
  • Cannulated surgical drill bit, single-use
  • Orthopaedic implantation sleeve, single-use
  • Suturing needle, single-use
  • Orthopaedic bone pin, non-bioabsorbable
Compact Plus Kit Low Profile System
Bioplate, Inc.
81-3367
In Commercial Distribution

  • M3848133670 ()
81-3367

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Xpress® Compact Kit
Bioplate, Inc.
81-3364
In Commercial Distribution

  • M3848133640 ()
81-3364

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Compact Plus Kit ø1.9mm System
Bioplate, Inc.
81-3342
In Commercial Distribution

  • M3848133420 ()
81-3342

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Compact Plus Kit ø1.5mm System
Bioplate, Inc.
81-3340
In Commercial Distribution

  • M3848133400 ()
81-3340

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
No Description
SMART DENTURE CONVERSIONS, LLC
PSK-ST
In Commercial Distribution

  • D990PSKST0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use
No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-SK
In Commercial Distribution

  • D990LXDGSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use
No Description
SMART DENTURE CONVERSIONS, LLC
LXDG-PSK
In Commercial Distribution

  • D990LXDGPSK0 ()


  • Steel dental bur, reusable
  • Surgical screwdriver, reusable
  • Dental implant suprastructure, temporary, preformed, single-use
  • Dental implant abutment analog, laboratory
  • Dental prosthesis/implant abutment screw
  • Dental prosthesis/implant abutment screw analog, single-use
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