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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The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440577
In Commercial Distribution

  • 04035479160531 ()
  • 04035479160616 ()

  • Width: 8.0 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440576
In Commercial Distribution

  • 04035479160524 ()
  • 04035479160623 ()

  • Width: 6.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • Cardiovascular patch, animal-derived
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1804
In Commercial Distribution

  • 09348215013226 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1604
In Commercial Distribution

  • 09348215013219 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1504
In Commercial Distribution

  • 09348215013202 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1404
In Commercial Distribution

  • 09348215013196 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1304
In Commercial Distribution

  • 09348215013189 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1204
In Commercial Distribution

  • 09348215013172 ()


  • Coated femoral stem prosthesis, modular
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