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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Instrument: Broach. 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-1000T-BRCH
In Commercial Distribution

  • 00810005662628 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Targeting Jig Plate Inserter. 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-1000T-JGIN
In Commercial Distribution

  • 00810005662611 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: 40mm Targeting Jig Drill Guide. 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-1000T-JG40
In Commercial Distribution

  • 00810005662604 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: 30mm Targeting Jig Drill Guide. 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-1000T-JG30
In Commercial Distribution

  • 00810005662598 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 3.0mm 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-1000T-DR30
In Commercial Distribution

  • 00810005662581 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Drill for 2.4mm 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-1000T-DR24
In Commercial Distribution

  • 00810005662574 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: AO Handle, Small. 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.
HAN-1000T-AOSM
In Commercial Distribution

  • 00810005660914 ()


  • General internal orthopaedic fixation system implantation kit
Instrument: Broach Extractor. 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-1000T-BRX
In Commercial Distribution

  • 00810005660907 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: Plate Extractor. 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-1000T-PLX
In Commercial Distribution

  • 00810005660891 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Instrument: Slotted Mallet. 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-1000T-MLT
In Commercial Distribution

  • 00810005660884 ()


  • General internal orthopaedic fixation system implantation kit
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 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 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
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 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 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 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
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 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 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
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 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 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
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWBE
In Commercial Distribution

  • 50197106729418 ()
  • 10197106729410 ()
SOPMIBPWBE

  • General surgical procedure kit, medicated
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM46
In Commercial Distribution

  • 50197106708291 ()
  • 10197106708293 ()
SCV31HVM46

  • Cardiothoracic surgical procedure kit, medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM45
In Commercial Distribution

  • 50197106599783 ()
  • 10197106599785 ()
SCV31HVM45

  • Cardiothoracic surgical procedure kit, medicated, single-use
Symmetry® Dilator, Castroviejo Lacrimal, Double-Ended
SYMMETRY SURGICAL INC.
60-1991
In Commercial Distribution

  • 00887482041093 ()
60-1991

  • Common bile duct dilator
Symmetry® Dilator, Bakes Common Duct, 1.0 mm Tip Width, 11 3/4 in
SYMMETRY SURGICAL INC.
51-0601
Not in Commercial Distribution

  • 00887482037621 ()

  • Length: 11.75 Inch
51-0601

  • Common bile duct dilator
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM38
In Commercial Distribution

  • 50197106109944 ()
  • 10197106109946 ()
SCV31HVM38

  • Cardiothoracic surgical procedure kit, medicated, single-use
BUNION PODIATRY PACK
Cardinal Health 200, LLC
SOPMIBPWB4
In Commercial Distribution

  • 50197106095179 ()
  • 10197106095171 ()
SOPMIBPWB4

  • General surgical procedure kit, medicated
AHD Luer Lock Cap
ARGON MEDICAL DEVICES, INC.
501303
In Commercial Distribution

  • 10886333215871 ()
  • 00886333215874 ()
  • 20886333215878 ()
501303

  • General-purpose catheter connector, sterile
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM37
In Commercial Distribution

  • 50197106081271 ()
  • 10197106081273 ()
SCV31HVM37

  • Cardiothoracic surgical procedure kit, medicated, single-use
Male/Female Luer Lock Plug
ARGON MEDICAL DEVICES, INC.
041295000A
In Commercial Distribution

  • 20886333201550 ()
  • 00886333201556 ()
041295000A

  • General-purpose catheter connector, sterile
Rotating Adapter with Doubel Male Luer Lock
ARGON MEDICAL DEVICES, INC.
041281000A
In Commercial Distribution

  • 20886333201529 ()
  • 00886333201525 ()
041281000A

  • General-purpose catheter connector, sterile
TRI-JECT 3-Way IV Administration Organizer without Stopcock
ARGON MEDICAL DEVICES, INC.
041230001A
In Commercial Distribution

  • 20886333201451 ()
  • 00886333201457 ()
041230001A

  • General-purpose catheter connector, sterile
Double Male LL Adapter Special Adapter to Convert a Female Fitting to Male LL
ARGON MEDICAL DEVICES, INC.
040184000A
In Commercial Distribution

  • 20886333201048 ()
  • 00886333201044 ()
040184000A

  • General-purpose catheter connector, sterile
Symmetry® Dilator, Ruedemann Lacrimal, Short
SYMMETRY SURGICAL INC.
60-1996
In Commercial Distribution

  • 00887482111468 ()
60-1996

  • Common bile duct dilator
Symmetry® Dilator, Wilder, Long, 4 in
SYMMETRY SURGICAL INC.
60-1995
In Commercial Distribution

  • 00887482111451 ()

  • Length: 4 Inch
60-1995

  • Common bile duct dilator
Symmetry® Dilator, Wilder, Medium, 4 in
SYMMETRY SURGICAL INC.
60-1994
In Commercial Distribution

  • 00887482111444 ()

  • Length: 4 Inch
60-1994

  • Common bile duct dilator
Symmetry® Dilator, Wilder, Short, 4 in
SYMMETRY SURGICAL INC.
60-1993
In Commercial Distribution

  • 00887482111437 ()

  • Length: 4 Inch
60-1993

  • Common bile duct dilator
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB7
In Commercial Distribution

  • 50197106231102 ()
  • 10197106231104 ()
SOP13BUJB7

  • Orthopaedic surgical procedure kit, non-medicated, single-use
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAK6
In Commercial Distribution

  • 50195594391988 ()
  • 10195594391980 ()
SNE29NEAK6

  • Neurosurgical procedure kit, non-medicated, single-use
NEUROLOGY INSTITUTE PACK
Cardinal Health 200, LLC
SNE29NEAKD
In Commercial Distribution

  • 50195594380579 ()
  • 10195594380571 ()
SNE29NEAKD

  • Neurosurgical procedure kit, non-medicated, single-use
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB2
In Commercial Distribution

  • 50195594378118 ()
  • 10195594378110 ()
SOP13BUJB2

  • Orthopaedic surgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE BASIN PK
Cardinal Health 200, LLC
SBA31BXMY2
In Commercial Distribution

  • 50195594189707 ()
  • 10195594189709 ()
SBA31BXMY2

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVMYJ
In Commercial Distribution

  • 50195594341013 ()
  • 10195594341015 ()
SCV31HVMYJ

  • Cardiothoracic surgical procedure kit, medicated, single-use
HEART VALVE INSTITUTE BASIN PK
Cardinal Health 200, LLC
SBA31BXMY3
In Commercial Distribution

  • 50195594273543 ()
  • 10195594273545 ()
SBA31BXMY3

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

  • 50195594239686 ()
  • 10195594239688 ()
SOPCGBNTFF

  • Orthopaedic surgical procedure kit, medicated
BUNION PACK
Cardinal Health 200, LLC
SOP13BUJB1
In Commercial Distribution

  • 50195594233202 ()
  • 10195594233204 ()
SOP13BUJB1

  • Orthopaedic surgical procedure kit, non-medicated, single-use
HEART VALVE INSTITUTE A B PACK
Cardinal Health 200, LLC
SCV31HVM27
In Commercial Distribution

  • 50195594182678 ()
  • 10195594182670 ()
SCV31HVM27

  • Cardiothoracic surgical procedure kit, medicated, single-use
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