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 Class Implantable

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SCREWDRIVER SHAFT WITH Q/C SELF-RETAINING/T25 STARDRIVE
SYNTHES (U.S.A.) LP
SD314.119
Not in Commercial Distribution

  • H679SD3141190 ()
  • 10886982004734 ()
SD314119

  • Surgical screwdriver, reusable
2.0MM DRILL BIT WITH Q/C/200MM LENGTH
Synthes GmbH
SD310.210
In Commercial Distribution

  • H679SD3102100 ()
  • 10886982003966 ()
SD310210

  • Fluted surgical drill bit, reusable
CORE PST ENM SH Q/C KIT 50g
DEN-MAT HOLDINGS, LLC
030616325
In Commercial Distribution

  • D8130306163250 ()
030616325

  • Dental composite resin
CORE PST Q/C W/FLUOR KIT 50g
DEN-MAT HOLDINGS, LLC
030612525
In Commercial Distribution

  • D8130306125250 ()
030612525

  • Dental composite resin
ESSENTIAL MED 3"P .5"B Q - S21057 BOX
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Convoluted Rollpack
Not in Commercial Distribution

  • H933F9005E0 ()
F9005E

  • Operating table patient pressure distribution pad, single-use
ESSENTIAL MED 2"P .5"B Q - S21057 BOX
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Convoluted Rollpack
Not in Commercial Distribution

  • H933F9002E0 ()
F9002E

  • Operating table patient pressure distribution pad, single-use
ESSENTIAL MED 4"P .5"B Q- S21057 BOX
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Convoluted Rollpack
Not in Commercial Distribution

  • H933F9008E0 ()
F9008E

  • Operating table patient pressure distribution pad, single-use
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.
RELIANCE ORTHODONTIC PRODUCTS INC
CIQA
Not in Commercial Distribution

  • D798CIQA0 ()
CIQA

  • Dentine bonding agent/set
A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device.
WHIP-MIX CORPORATION
9185Q
In Commercial Distribution

  • D040343581 ()
9185Q

  • Facebow
A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosis, or to construct dental appliances. This is a reusable device.
WHIP-MIX CORPORATION
34220
In Commercial Distribution

  • D040342201 ()
34220

  • Dental articulator
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