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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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Ambi-Gard Blue Nitrile Exam Gloves, Size 2XL
Saf-T-Gard International, Inc.
8670/2XL
In Commercial Distribution

  • G53986702XL2 ()
  • G53986702XL1 ()
  • G53986702XL0 ()
8670/2XL

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Vela Operations USA Inc.
01
In Commercial Distribution

  • G491CDF21 ()
  • G491CDF20 ()
300786

  • Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Endolumik Gastric Calibration Tube, 40F
Endolumik, Inc.
EGCT40
In Commercial Distribution

  • G461EGCT400 ()
  • G461EGCT401 ()

  • Circumference: 41.9 Millimeter


  • Gastric calibration tube
Endolumik Gastric Calibration Tube 36F
Endolumik, Inc.
EGCT36
In Commercial Distribution

  • G461EGCT361 ()
  • G461EGCT360 ()

  • Circumference: 37.3 Millimeter


  • Gastric calibration tube
PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin. PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
LV+G
Not in Commercial Distribution

  • J014001119140011 ()
  • J014001119140012 ()
00-1119-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
R
Not in Commercial Distribution

  • J014002112140011 ()
  • J014001112140012 ()
00-1112-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Heraeus Medical GmbH
LV
Not in Commercial Distribution

  • J014001118140011 ()
  • J014001118140012 ()
00-1118-140-01

  • Orthopaedic cement, non-antimicrobial
PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation.
Heraeus Medical GmbH
R+G
Not in Commercial Distribution

  • J014001113140011 ()
  • J014001113140012 ()
00-1113-140-01

  • Orthopaedic cement, non-antimicrobial
Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Bien-Air Dental SA
1600617-001
In Commercial Distribution

  • J00716006170011 ()
  • J00716006170061 ()
1600617-001

  • Surgical instrument maintenance lubricant
Maintenance products (cleaning the device and lubricate the active parts as ball bearings)are intended for use in dentistry by professional users, to maintain the proper and safe functioning of the dental instruments
Bien-Air Dental SA
1600064-001
In Commercial Distribution

  • J00716000640011 ()
  • J00716000640061 ()
1600064-001

  • Surgical instrument maintenance lubricant
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