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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0803
In Commercial Distribution

  • 09348215051730 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1802
In Commercial Distribution

  • 09348215051723 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1602
In Commercial Distribution

  • 09348215051716 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1502
In Commercial Distribution

  • 09348215051709 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1402
In Commercial Distribution

  • 09348215051693 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1302
In Commercial Distribution

  • 09348215051686 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1202
In Commercial Distribution

  • 09348215051679 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1102
In Commercial Distribution

  • 09348215051662 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1002
In Commercial Distribution

  • 09348215051655 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0902
In Commercial Distribution

  • 09348215051648 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0802
In Commercial Distribution

  • 09348215051631 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1801
In Commercial Distribution

  • 09348215051624 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1601
In Commercial Distribution

  • 09348215051617 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1501
In Commercial Distribution

  • 09348215051600 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1401
In Commercial Distribution

  • 09348215051594 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1301
In Commercial Distribution

  • 09348215051587 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1201
In Commercial Distribution

  • 09348215051570 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1101
In Commercial Distribution

  • 09348215051563 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1001
In Commercial Distribution

  • 09348215051556 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0901
In Commercial Distribution

  • 09348215051549 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1800
In Commercial Distribution

  • 09348215051532 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1600
In Commercial Distribution

  • 09348215051525 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1500
In Commercial Distribution

  • 09348215051518 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1400
In Commercial Distribution

  • 09348215051501 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1300
In Commercial Distribution

  • 09348215051495 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1200
In Commercial Distribution

  • 09348215051488 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1100
In Commercial Distribution

  • 09348215051471 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1000
In Commercial Distribution

  • 09348215051464 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0900
In Commercial Distribution

  • 09348215051457 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0800
In Commercial Distribution

  • 09348215051440 ()


  • Coated femoral stem prosthesis, modular
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.
440579
In Commercial Distribution

  • 04035479160647 ()
  • 04035479160555 ()

  • SubQ


  • 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.
440578
In Commercial Distribution

  • 04035479160548 ()
  • 04035479160654 ()

  • Width: 9.5 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.
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
XenoSure Biologic Pledgets, 0.5cm x 1.0cm
Lemaitre Vascular, Inc.
PL0510R25
In Commercial Distribution

  • 00840663109357 ()
PL0510R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.5cm x 0.6cm, 25-Count
Lemaitre Vascular, Inc.
PL0506R25
In Commercial Distribution

  • 00840663109340 ()
PL0506R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.3cm x 0.7cm
Lemaitre Vascular, Inc.
PL0307R25
In Commercial Distribution

  • 00840663109333 ()
PL0307R25

  • Cardiovascular patch, animal-derived
XenoSure Thick Biologic Patch, 10 x 16cm - eP
Lemaitre Vascular, Inc.
e10P16T
In Commercial Distribution

  • 00840663109227 ()
e10P16T

  • Cardiovascular patch, animal-derived
XenoSure Thick Biologic Patch, 6 x 8cm - eP
Lemaitre Vascular, Inc.
e6P8T
In Commercial Distribution

  • 00840663109210 ()
e6P8T

  • Cardiovascular patch, animal-derived
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