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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Connecting Tube for Drainage Bag with Funnel Adaptors
BOSTON SCIENTIFIC CORPORATION
M001229100
In Commercial Distribution

  • 08714729115564 ()
  • 08714729735649 ()

  • 30 cm Effective Length


  • General-purpose catheter connector, sterile
Multi-Adj Facemask Union Jack
ORTHO TECHNOLOGY, INC.
550-410
In Commercial Distribution

  • 00190730002730 ()


  • Orthodontic extraoral headgear
Facemask Replace PadKit Union Jack 2 Head/2 Chin Foam/HexKey
ORTHO TECHNOLOGY, INC.
410-RK2
In Commercial Distribution

  • 00190730011664 ()


  • Orthodontic extraoral headgear
Y-Sets
BOSTON SCIENTIFIC CORPORATION
104834-0020
In Commercial Distribution

  • 08714729888970 ()
  • 08714729888963 ()


  • General-purpose catheter connector, sterile
Connecting Tube
BOSTON SCIENTIFIC CORPORATION
H7493938000150
In Commercial Distribution

  • 08714729862925 ()
  • 08714729862949 ()

  • 15 cm Length


  • General-purpose catheter connector, sterile
Collagen Guided Healing Membrane
DILON TECHNOLOGIES FRANCE
MCG 15 68 AD
Not in Commercial Distribution

  • 03760193182590 ()

  • Length: 80 Millimeter
  • Width: 60 Millimeter
COUS68

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Collagen Guided Healing Membrane
DILON TECHNOLOGIES FRANCE
MCG 14 46 AD
Not in Commercial Distribution

  • 03760193182583 ()

  • Length: 60 Millimeter
  • Width: 40 Millimeter
COUS46

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Collagen Guided Healing Membrane
DILON TECHNOLOGIES FRANCE
MCG 13 34 AD
Not in Commercial Distribution

  • 03760193182576 ()

  • Length: 40 Millimeter
  • Width: 30 Millimeter
COUS34

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Collagen Guided Healing Membrane
DILON TECHNOLOGIES FRANCE
MCG 11 12 AD
Not in Commercial Distribution

  • 03760193182552 ()

  • Length: 25 Millimeter
  • Width: 15 Millimeter
COUS12

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM48
In Commercial Distribution

  • 50197106766123 ()
  • 10197106766125 ()
SCV31HVM48

  • Cardiothoracic surgical procedure kit, medicated, single-use
PeakSonic M5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes.
Suzhou PeakSonic Medical Technology Co.,LTD.
M5
In Commercial Distribution

  • 06975124100773 ()


  • Bladder volume ultrasound imaging system
HEART VALVE INSTITUTE BASIN PK
Cardinal Health 200, LLC
SBA31BXMYB
In Commercial Distribution

  • 50197106711536 ()
  • 10197106711538 ()
SBA31BXMYB

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWBE
In Commercial Distribution

  • 50197106729418 ()
  • 10197106729410 ()
SOPMIBPWBE

  • General surgical procedure kit, medicated
No Description
Wuhan Huchuang Union Technology Co., Ltd.
TLS301
In Commercial Distribution

  • 06975737430120 ()


  • Assisted reproduction procedure dish
No Description
Wuhan Huchuang Union Technology Co., Ltd.
D-CK1000
In Commercial Distribution

  • 06975737430113 ()


  • Assisted reproduction procedure dish
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM47
In Commercial Distribution

  • 50197106737581 ()
  • 10197106737583 ()
SCV31HVM47

  • Cardiothoracic surgical procedure kit, medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM49
In Commercial Distribution

  • 50197106784387 ()
  • 10197106784389 ()
SCV31HVM49

  • Cardiothoracic surgical procedure kit, medicated, single-use
Tray: MIS Bunion K-Wire Tube. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000C-105
In Commercial Distribution

  • 00810005667852 ()


  • Surgical instrument/implant rack
Tray: MIS Bunion Caddy Lid. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000C-104
In Commercial Distribution

  • 00810005667845 ()


  • Surgical instrument/implant rack
Tray: MIS Bunion Caddy Base. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000C-103
In Commercial Distribution

  • 00810005667838 ()


  • Surgical instrument/implant rack
Tray: MIS Bunion Tray Lid. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000C-102
In Commercial Distribution

  • 00810005667821 ()


  • Surgical instrument/implant rack
Tray: MIS Bunion Tray Base. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-1000C-101
In Commercial Distribution

  • 00810005667814 ()


  • Surgical instrument/implant rack
Javelin Screw Caddy Lid. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-1000C-104
In Commercial Distribution

  • 00810005667807 ()


  • Surgical instrument/implant rack
5.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUN-PLT-05
In Commercial Distribution

  • 00810005665704 ()

  • Height: 5.0 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Plate 40mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-40-4
In Commercial Distribution

  • 00810005665698 ()

  • Length: 40 Millimeter


  • External orthopaedic fixation system, single-use
Plate 30mm long. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-4
In Commercial Distribution

  • 00810005665681 ()

  • Length: 30 Millimeter


  • External orthopaedic fixation system, single-use
3.00mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-16N
In Commercial Distribution

  • 00810005665674 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-14N
In Commercial Distribution

  • 00810005665667 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-12N
In Commercial Distribution

  • 00810005665650 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 10mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-10N
In Commercial Distribution

  • 00810005665643 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 8mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-08N
In Commercial Distribution

  • 00810005665636 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 6mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-06N
In Commercial Distribution

  • 00810005665629 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 16mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-16N
In Commercial Distribution

  • 00810005665612 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 14mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-14N
In Commercial Distribution

  • 00810005665605 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 12mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-12N
In Commercial Distribution

  • 00810005665599 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 10mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-10N
In Commercial Distribution

  • 00810005665582 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 8mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-08N
In Commercial Distribution

  • 00810005665575 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 6mm long non-locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-06N
In Commercial Distribution

  • 00810005665568 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 16mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-16L
In Commercial Distribution

  • 00810005665551 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 14mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-14L
In Commercial Distribution

  • 00810005665544 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 12mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-12L
In Commercial Distribution

  • 00810005665537 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 10mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-10L
In Commercial Distribution

  • 00810005665520 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 10 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 8mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-08L
In Commercial Distribution

  • 00810005665421 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 8 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.00mm dia 6mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-30-06L
In Commercial Distribution

  • 00810005665414 ()

  • Outer Diameter: 3.00 Millimeter
  • Length: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 16mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-16L
In Commercial Distribution

  • 00810005665407 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 16 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 14mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-14L
In Commercial Distribution

  • 00810005665391 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 14 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 12mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-12L
In Commercial Distribution

  • 00810005665384 ()

  • Outer Diameter: 2.40 Millimeter
  • Length: 12 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 10mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-10L
In Commercial Distribution

  • 00810005665377 ()

  • Length: 10 Millimeter
  • Outer Diameter: 2.40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 8mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-08L
In Commercial Distribution

  • 00810005665360 ()

  • Length: 8 Millimeter
  • Outer Diameter: 2.40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
2.40mm dia 6mm long locking screw. The Javelin Tailor’s Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
TB-24-06L
In Commercial Distribution

  • 00810005665353 ()

  • Length: 6 Millimeter
  • Outer Diameter: 6 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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