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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Mistral-Air® Premium Warming Suit, Medium - SYK
The Surgical Company International B.V.
MA1620-PM
In Commercial Distribution

  • ET37MA1620PM0 ()
  • ET37MA1620PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Premium Warming Suit, Small - SYK
The Surgical Company International B.V.
MA1610-PM
In Commercial Distribution

  • ET37MA1610PM0 ()
  • ET37MA1610PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Tube - SYK
The Surgical Company International B.V.
MA0510-PM
In Commercial Distribution

  • ET37MA0510PM0 ()
  • ET37MA0510PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Underbody Reflective - SYK
The Surgical Company International B.V.
MA0450-PM
In Commercial Distribution

  • ET37MA0450PM0 ()
  • ET37MA0450PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Full Underbody Reflective - SYK
The Surgical Company International B.V.
MA0400-PM
In Commercial Distribution

  • ET37MA0400PM0 ()
  • ET37MA0400PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Half Upper Body Reflective - SYK
The Surgical Company International B.V.
MA0365-PM
In Commercial Distribution

  • ET37MA0365PM0 ()
  • ET37MA0365PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Upper Body Reflective - SYK
The Surgical Company International B.V.
MA0360-PM
In Commercial Distribution

  • ET37MA0360PM0 ()
  • ET37MA0360PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Lower Body Reflective - SYK
The Surgical Company International B.V.
MA0350-PM
In Commercial Distribution

  • ET37MA0350PM0 ()
  • ET37MA0350PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Neonatal Reflective - SYK
The Surgical Company International B.V.
MA0340-PM
In Commercial Distribution

  • ET37MA0340PM0 ()
  • ET37MA0340PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Paediatric Reflective - SYK
The Surgical Company International B.V.
MA0330-PM
In Commercial Distribution

  • ET37MA0330PM0 ()
  • ET37MA0330PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Adult Reflective - SYK
The Surgical Company International B.V.
MA0320-PM
In Commercial Distribution

  • ET37MA0320PM0 ()
  • ET37MA0320PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
Mistral-Air® Faceshield – SYK
The Surgical Company International B.V.
MA02010-PM
In Commercial Distribution

  • ET37MA02010PM0 ()
  • ET37MA02010PM1 ()


  • External circulating-air core temperature regulation system pad, single-use
OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (25x30mm)
Dentsply Implants Manufacturing GmbH
USOSTRNRM2530
In Commercial Distribution

  • EFRIOSTRNRM25301 ()
  • EFRIOSTRNRM25300 ()
OSTRNRM2530

  • Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
OsteoShield® Titanium-Reinforced Non-Resorbable Membrane (12x20mm)
Dentsply Implants Manufacturing GmbH
USOSTRNRM1220
In Commercial Distribution

  • EFRIOSTRNRM12201 ()
  • EFRIOSTRNRM12200 ()
OSTRNRM1220

  • Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
OsteoShield® PTFE Non-Resorbable Membrane (25x30mm)
Dentsply Implants Manufacturing GmbH
USOSNRM2530
In Commercial Distribution

  • EFRIOSNRM25301 ()
  • EFRIOSNRM25300 ()
OSNRM2530

  • Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
OsteoShield® PTFE Non-Resorbable Membrane (12x24mm)
Dentsply Implants Manufacturing GmbH
USOSNRM1224
In Commercial Distribution

  • EFRIOSNRM12241 ()
  • EFRIOSNRM12240 ()
OSNRM1224

  • Pliable-polymer dental regeneration membrane, bioabsorbable, ligated
OsteoShield® Collagen Resorbable Membrane (30x40mm)
Dentsply Implants Manufacturing GmbH
USOSCRM3040
In Commercial Distribution

  • EFRIOSCRM30401 ()
  • EFRIOSCRM30400 ()
OSCRM3040

  • Collagen dental regeneration membrane
OsteoShield® Collagen Resorbable Membrane (20x30mm)
Dentsply Implants Manufacturing GmbH
USOSCRM2030
In Commercial Distribution

  • EFRIOSCRM20301 ()
  • EFRIOSCRM20300 ()
OSCRM2030

  • Collagen dental regeneration membrane
OsteoShield® Collagen Resorbable Membrane (15x20mm)
Dentsply Implants Manufacturing GmbH
USOSCRM1520
In Commercial Distribution

  • EFRIOSCRM15201 ()
  • EFRIOSCRM15200 ()
OSCRM1520

  • Collagen dental regeneration membrane
OSTEOGRAF/N-700 (4x3.0g)
Dentsply Implants Manufacturing GmbH
970000304
Not in Commercial Distribution

  • EFRI9700003042 ()
  • EFRI9700003041 ()
970000304

  • Dental bone matrix implant, animal-derived
OSTEOGRAF/N-700 (4x1.0g)
Dentsply Implants Manufacturing GmbH
970000104
Not in Commercial Distribution

  • EFRI9700001042 ()
  • EFRI9700001041 ()
970000104

  • Dental bone matrix implant, animal-derived
OSTEOGRAF/LD-300 (4x3.0g)
Dentsply Implants Manufacturing GmbH
940000304
Not in Commercial Distribution

  • EFRI9400003042 ()
  • EFRI9400003041 ()
940000304

  • Dental bone matrix implant, synthetic
OSTEOGRAF/LD-300 (4x1.0g)
Dentsply Implants Manufacturing GmbH
940000104
Not in Commercial Distribution

  • EFRI9400001042 ()
  • EFRI9400001041 ()
940000104

  • Dental bone matrix implant, synthetic
OSTEOGRAF /LD-300 (4x0.5g)
Dentsply Implants Manufacturing GmbH
940000054
Not in Commercial Distribution

  • EFRI9400000542 ()
  • EFRI9400000541 ()
940000054

  • Dental bone matrix implant, synthetic
OSTEOGRAF/N-300 (4x3.0g)
Dentsply Implants Manufacturing GmbH
930000304
Not in Commercial Distribution

  • EFRI9300003042 ()
  • EFRI9300003041 ()
930000304

  • Dental bone matrix implant, animal-derived
OSTEOGRAF/N-300 (4x1.0g)
Dentsply Implants Manufacturing GmbH
930000104
Not in Commercial Distribution

  • EFRI9300001042 ()
  • EFRI9300001041 ()
930000104

  • Dental bone matrix implant, animal-derived
OSTEOGRAF/D-300 (4x1.0g)
Dentsply Implants Manufacturing GmbH
920000104
Not in Commercial Distribution

  • EFRI9200001042 ()
  • EFRI9200001041 ()
920000104

  • Dental bone matrix implant, synthetic
OSTEOGRAF/D-700 (4x3.0g)
Dentsply Implants Manufacturing GmbH
900000304
Not in Commercial Distribution

  • EFRI9000003042 ()
  • EFRI9000003041 ()
900000304

  • Dental bone matrix implant, synthetic
OSTEOGRAF/D-700 (4x1.0g)
Dentsply Implants Manufacturing GmbH
900000104
Not in Commercial Distribution

  • EFRI9000001042 ()
  • EFRI9000001041 ()
900000104

  • Dental bone matrix implant, synthetic
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163312
In Commercial Distribution

  • M711TXT121633121 ()
  • M711TXT121633120 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12163312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163310
In Commercial Distribution

  • M711TXT121633101 ()
  • M711TXT121633100 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12163310

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12163305
In Commercial Distribution

  • M711TXT121633051 ()
  • M711TXT121633050 ()

  • Width: 12 Millimeter
  • Height: 16 Millimeter
  • Length: 33 Millimeter
  • Angle: 5 degree
TXT12163305

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153312
In Commercial Distribution

  • M711TXT121533121 ()
  • M711TXT121533120 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12153312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153310
In Commercial Distribution

  • M711TXT121533101 ()
  • M711TXT121533100 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12153310

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12153305
In Commercial Distribution

  • M711TXT121533051 ()
  • M711TXT121533050 ()

  • Width: 12 Millimeter
  • Height: 15 Millimeter
  • Length: 33 Millimeter
  • Angle: 5 degree
TXT12153305

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12143312
In Commercial Distribution

  • M711TXT121433121 ()
  • M711TXT121433120 ()

  • Width: 12 Millimeter
  • Height: 14 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12143312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12143310
In Commercial Distribution

  • M711TXT121433101 ()
  • M711TXT121433100 ()

  • Width: 12 Millimeter
  • Height: 14 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12143310

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12143305
In Commercial Distribution

  • M711TXT121433051 ()
  • M711TXT121433050 ()

  • Width: 12 Millimeter
  • Height: 14 Millimeter
  • Length: 33 Millimeter
  • Angle: 5 degree
TXT12143305

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12133312
In Commercial Distribution

  • M711TXT121333121 ()
  • M711TXT121333120 ()

  • Width: 12 Millimeter
  • Height: 13 Millimeter
  • Length: 33 Millimeter
  • Angle: 12.5 degree
TXT12133312

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
TXT12133310
In Commercial Distribution

  • M711TXT121333101 ()
  • M711TXT121333100 ()

  • Width: 12 Millimeter
  • Height: 13 Millimeter
  • Length: 33 Millimeter
  • Angle: 10 degree
TXT12133310

  • Metallic spinal interbody fusion cage
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