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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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Fix mount drencher shower head, chrome
WATER PIK, INC.
XMT-633E
Not in Commercial Distribution

  • 00073950259033 ()
XMT-633E

  • External manual massager, home-use
Hand held shower head, chrome
WATER PIK, INC.
LBT-563M
Not in Commercial Distribution

  • 00073950254137 ()
LBT-563M

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XMD-639E
Not in Commercial Distribution

  • 00073950247979 ()
XMD-639E

  • External manual massager, home-use
Fix mount drencher shower head, brushed nickel
WATER PIK, INC.
XMT-639
Not in Commercial Distribution

  • 00073950236119 ()
XMT-639

  • External manual massager, home-use
Weight scale with wireless communication - Bluetooth
Omron Healthcare, Inc.
SC-150
In Commercial Distribution

  • 10073796931503 ()
  • 00073796931506 ()
SC-150

  • Stand-on floor scale, electronic
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45GIATHN
In Commercial Distribution

  • 50085412658839 ()
  • 00085412658834 ()

  • Length: 45 Millimeter
PSDA45GIATHN

  • Staple line-reinforcement strip
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45GIA
In Commercial Distribution

  • 50085412658686 ()
  • 00085412658681 ()

  • Length: 45 Millimeter
PSDA45GIA

  • Staple line-reinforcement strip
This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
BAXTER HEALTHCARE CORPORATION
5C4466P
In Commercial Distribution

  • 50085412007699 ()
  • 00085412007694 ()
5C4466P

  • Peritoneal dialysis system tubing set
MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.111US
In Commercial Distribution

  • 08031497002163 ()


  • Orthopaedic cement, antimicrobial
MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
TECRES SPA
65.01.113US
In Commercial Distribution

  • 08031497002149 ()


  • Orthopaedic cement, antimicrobial
Femur with Aurum, size 7
TOTAL JOINT ORTHOPEDICS, INC.
5104.07.000
In Commercial Distribution

  • 00814703017100 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 6
TOTAL JOINT ORTHOPEDICS, INC.
5104.06.000
In Commercial Distribution

  • 00814703017094 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 5
TOTAL JOINT ORTHOPEDICS, INC.
5104.05.000
In Commercial Distribution

  • 00814703017087 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 4
TOTAL JOINT ORTHOPEDICS, INC.
5104.04.000
In Commercial Distribution

  • 00814703017070 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 3
TOTAL JOINT ORTHOPEDICS, INC.
5104.03.000
In Commercial Distribution

  • 00814703017063 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 2
TOTAL JOINT ORTHOPEDICS, INC.
5104.02.000
In Commercial Distribution

  • 00814703017056 ()


  • Uncoated knee femur prosthesis, metallic
Femur with Aurum, size 1
TOTAL JOINT ORTHOPEDICS, INC.
5104.01.000
In Commercial Distribution

  • 00814703017049 ()


  • Uncoated knee femur prosthesis, metallic
AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315F
In Commercial Distribution

  • 00813787021317 ()


  • Manual brachytherapy source, permanent implant
AnchorSeed/TSL in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77315N
In Commercial Distribution

  • 00813787021300 ()


  • Manual brachytherapy source, permanent implant
Loose VariStrand with 1-9 seeds, standard spacing
THERAGENICS CORPORATION
XX772xL
In Commercial Distribution

  • 00813787021256 ()


  • Manual brachytherapy source, permanent implant
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