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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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Assure Plus - D798UAP501

Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system.
RELIANCE ORTHODONTIC PRODUCTS INC
UAP50
Not in Commercial Distribution

  • D798UAP501 ()
  • D798UAP500 ()
  • D798UAP502 ()
UAP50

  • Dentine bonding agent/set

Rely A Bond - D798RPT1

Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. Rely•a•Bond® is a No Mix Bonding System that sets on contact. This is the Rely A Bond 14g Adhesive paste in Tips.
RELIANCE ORTHODONTIC PRODUCTS INC
RPT
In Commercial Distribution

  • D798RPT1 ()
  • D798RPT0 ()
  • D798RPT2 ()
RPT

  • Orthodontic bracket adhesive

Endure - B531STS162020

Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile
ENDURE INDUSTRIES
STS162021217
In Commercial Distribution

  • B531STS162020 ()
  • B531STS162022 ()

  • Lumen/Inner Diameter: .25 Inch
  • Length: 2 Meter
STS16202

  • Suction/irrigation tubing, single-use

Negative Pressure Wound Therapy System Foam Dressing - B530UTD250

NPWT Ported Dome pad
LC MEDICAL CONCEPTS
UTD24
In Commercial Distribution

  • B530UTD241 ()
  • B530UTD250 ()
UTD24

  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

CLEO - B5331191500

Ultraviolet tanning device
BLV Licht- und Vakuumtechnik GmbH
HPA 700/800 FX C
Not in Commercial Distribution

  • B5331191500 ()
  • B533119151 ()
119150

  • Ultraviolet tanning device

COSMEDICO - B5331181260

No Description
BLV Licht- und Vakuumtechnik GmbH
M 400W R7s
Not in Commercial Distribution

  • B5331181261 ()
  • B5331181260 ()
  • B5331036990 ()
118126

  • Ultraviolet tanning device

SUPRA - B5331181230

No Description
BLV Licht- und Vakuumtechnik GmbH
Q-04500SI
Not in Commercial Distribution

  • B5331181231 ()
  • B5331181230 ()
  • B5331037010 ()
118123

  • Ultraviolet tanning device

RADIANCE - B5331181220

No Description
BLV Licht- und Vakuumtechnik GmbH
HP 400-500W R7s
In Commercial Distribution

  • B5331181221 ()
  • B5331181220 ()
  • B5331037000 ()
118122

  • Ultraviolet tanning device

COSMEDICO - B5331181190

No Description
BLV Licht- und Vakuumtechnik GmbH
M 500 R7s
Not in Commercial Distribution

  • B5331181191 ()
  • B5331181190 ()
  • B5331035980 ()
118119

  • Ultraviolet tanning device

CLEO - B5331181140

No Description
BLV Licht- und Vakuumtechnik GmbH
HPA 700 S FX
Not in Commercial Distribution

  • B5331181141 ()
  • B5331181140 ()
  • B5331039340 ()
118114

  • Ultraviolet tanning device
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