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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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Enhance™ L.C. is intended for use as a light cure adhesion booster to: fluorosed, hypocalcified or deciduous enamel, saliva contaminated enamel, enamel where maximum adhesion is required, metal surfaces (gold, amalgam, stainless steel) and acrylic, porcelain or composite restorations.
RELIANCE ORTHODONTIC PRODUCTS INC
LCE6
In Commercial Distribution

  • D798LCE60 ()
LCE6

  • Dentine bonding agent/set
The CRoC is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas. The CRoC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.
Safeguard US Operating, LLC
C
Not in Commercial Distribution

  • M68931200C0 ()
31-200

  • Emergency junctional haemorrhage compression set
Examination/treatment table with some articulated sections that can be adjusted into various accommodations for patient comfort and/or treatment. The height of the table surface is power-adjusted or fixed height. It is typically used by physical therapists and chiropractors.
Leander, LLC
STAT
In Commercial Distribution

  • G509SERIESSTAT0 ()


  • Examination/treatment table, line-powered
The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to the Integra Camino ICP Monitor. It is an eight foot long silicone cable, with circular PEI (polyetherimide) connectors and a Ferrite clamp on suppressor.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
FLEXEXT
Not in Commercial Distribution

  • M273FLEXEXT1 ()
  • 10381780040965 ()

  • 8ft length


  • Electrical-only medical device connection cable, reusable
The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System, intended to be used on patients exhibiting acute respiratory distress. The 8800 model is packaged with a Large Adult CPAP mask and pre-attached bonnet.
B.L.S. Systems Limited
8800
In Commercial Distribution

  • B00288001 ()
  • B00288000 ()

  • Large CPAP Mask
8800

  • CPAP/BPAP face mask, single-use
V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209VA2X00 ()


  • Radiological PACS software
Trel-XC Putty, 10cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXCPY10
In Commercial Distribution

  • M386TXCPY101 ()
  • 10381780112464 ()

  • 10cc
TXCPY10

  • Bone matrix implant, human-derived
Trel-XC Putty, 5cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXCPY05
In Commercial Distribution

  • M386TXCPY051 ()
  • 10381780112457 ()

  • 5cc
TXCPY05

  • Bone matrix implant, human-derived
Trel-XC Paste, 8cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXCPA08
In Commercial Distribution

  • M386TXCPA081 ()
  • 10381780112440 ()

  • 8cc
TXCPA08

  • Bone matrix implant, human-derived
Trel-XC Paste, 3cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXCPA03
In Commercial Distribution

  • M386TXCPA031 ()
  • 10381780112433 ()

  • 3cc
TXCPA03

  • Bone matrix implant, human-derived
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