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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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Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8705M0
In Commercial Distribution

  • 07640123791138 ()

  • Total Volume: 1.0 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic
Belotero Balance is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2 in, 30G x 1/2 in), and (3) two patient record labels.
ANTEIS SA
8700M0
In Commercial Distribution

  • 07640123791121 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 27 Gauge
  • Needle Gauge: 30 Gauge


  • Dermal tissue reconstructive material, microbe-derived
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-27/29
In Commercial Distribution

  • 00851788001549 ()

  • Outer Diameter: 27 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 29 Millimeter
ONXAAP-27/29

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-25
In Commercial Distribution

  • 00851788001532 ()

  • Outer Diameter: 25 Millimeter
ONXAAP-25

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-23
In Commercial Distribution

  • 00851788001525 ()

  • Outer Diameter: 23 Millimeter
ONXAAP-23

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-21
In Commercial Distribution

  • 00851788001518 ()

  • Outer Diameter: 21 Millimeter
ONXAAP-21

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-19
In Commercial Distribution

  • 00851788001501 ()

  • Outer Diameter: 19 Millimeter
ONXAAP-19

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
In Commercial Distribution

80008-004

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-003
In Commercial Distribution

  • 00840241600030 ()
80008-003

  • Wearable defibrillation system defibrillator
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (single unit package).
CARDIOCOMMAND, INC.
2A re-man'd, single pack
In Commercial Distribution

  • 10856233005155 ()
8002A-9999

  • External pacemaker, transoesophageal pacing
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