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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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PRESSURE MONITORING SET
Edwards Lifesciences LLC
T443952B
In Commercial Distribution

  • 57460691930174 ()
  • 07460691930179 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 54 INCH (136 CENTIMETER)
T443952B

  • Arterial blood sampling kit
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T432104B
In Commercial Distribution

  • 57460691925736 ()
  • 07460691925731 ()

  • TOTAL VOLUME: 3 MILLILITER, LENGTH: 98 INCH (250 CENTIMETER)
T432104B

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T430140A
In Commercial Distribution

  • 57460691924845 ()
  • 07460691924840 ()

  • TOTAL VOLUME: 3 MILLILITER, LENGTH: 75 INCH (190 CENTIMETER)
T430140A

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T434501B
In Commercial Distribution

  • 57460691956631 ()
  • 07460691956636 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 88 INCH (225 CENTIMETER)
T434501B

  • Invasive-pressure external transducer, single-use
The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-7 device is preloaded strands with Markers.
ISORAY MEDICAL, INC.
PL-7
Not in Commercial Distribution

  • M748PL70 ()


  • General-purpose brachytherapy system applicator, manual
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
OSBA-001
In Commercial Distribution

  • 05060548020217 ()
OSBA-001

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
OBS1202
In Commercial Distribution

  • 05060548020095 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
OBS1201
In Commercial Distribution

  • 05060548020088 ()
OBS1201

  • Bone matrix implant, synthetic, non-antimicrobial
Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe, . They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box.
BIOSTONE CO. LIMITED
OBS1205
In Commercial Distribution

  • 05060548020002 ()
OBS1205

  • Bone matrix implant, synthetic, non-antimicrobial
Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe, . They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box.
BIOSTONE CO. LIMITED
SYS205
In Commercial Distribution

  • 05060548020521 ()
SYS205

  • Bone matrix implant, synthetic, non-antimicrobial
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