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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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Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box.
BIOSTONE CO. LIMITED
SYS210M
In Commercial Distribution

  • 05060548020552 ()
SYS210M

  • 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 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.
BIOSTONE CO. LIMITED
SYS205M
In Commercial Distribution

  • 05060548020545 ()
SYS205M

  • 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 10 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
SYS210
In Commercial Distribution

  • 05060548020538 ()
SYS210

  • 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
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 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
SYS203
In Commercial Distribution

  • 05060548020514 ()
SYS203

  • 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
SYS202
In Commercial Distribution

  • 05060548020507 ()
SYS202

  • 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
SYS201
In Commercial Distribution

  • 05060548020491 ()
SYS201

  • Bone matrix implant, synthetic, non-antimicrobial
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600436-001
In Commercial Distribution

  • J00716004360011 ()
1600436-001

  • Dental power tool system handpiece, remotely-driven
Dental impression material mixer, Brand Kulzer GmbH
Renfert GmbH
2562001000
In Commercial Distribution

  • J00925620010000 ()
2562001000

  • Dental impression material mixer
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA22.5
In Commercial Distribution

  • 00850008515026 ()

  • Weight: 2.5 Gram


  • Hygroscopic dental cement
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA21.0
In Commercial Distribution

  • 00850008515019 ()

  • Weight: 1.0 Gram
none

  • Hygroscopic dental cement
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
NUSMILE, LTD.
NMTA20.5
In Commercial Distribution

  • 00850008515002 ()

  • Weight: 0.5 Gram
none

  • Hygroscopic dental cement
Multi Position Stander
RIFTON EQUIPMENT
S420
In Commercial Distribution

  • 00850001752350 ()


  • Manual stander
VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of 1% Eosin Y in saline (product code: VITAL_1 and 30ml of 5% Nigrosin in saline (product code: VITAL_2). The eosin-nigrosin staining technique is based on the principle that dead cells will take up the eosin and as a result stain red. The nigrosin provides a dark background which makes it easier to assess the slides. The VitalScreen™ is based on the test procedure described in the WHO laboratory manual (2010). VitalScreen™ has a 24 month shelf life from date of produce. Reference is made to the product page of VitalScreen on the FertiPro website: www.fertipro.com
Fertipro NV
VITAL_2
In Commercial Distribution

  • 05411967001774 ()

  • Total Volume: 30 Milliliter


  • Biological stain IVD
Calibration gas 2, 10bar on-board gas bottle for USA and Canada
Radiometer Medical ApS
962-175
In Commercial Distribution

  • 05700699621757 ()
962-175

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Calibration gas 2, 10bar on-board gas bottle
Radiometer Medical ApS
962-170
Not in Commercial Distribution

  • 05700699621702 ()
962-170

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
Gas cylinder 2.5L Gas 2: 11.22 % CO2, 0 % O2
Radiometer Medical ApS
962-141
Not in Commercial Distribution

  • 05700699621412 ()
962-141

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
S1830 Calibration Solution 2, 200 mL, for ABL800 FLEX
Radiometer Medical ApS
944-129
In Commercial Distribution

  • 05700699441294 ()
944-129

  • Multiple blood gas analyte IVD, calibrator
No Description
BIOCARE MEDICAL LLC
OPRI6045T60
In Commercial Distribution

  • 00847627025005 ()


  • Immunohistochemistry antibody detection IVD, reagent
No Description
SEKISUI DIAGNOSTICS, LLC
SM-056
Not in Commercial Distribution

  • 00628063400461 ()
  • 10628063400468 ()
SM-056

  • Multiple-type clinical chemistry analyte profile IVD, control
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