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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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The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135012
Not in Commercial Distribution

  • M248281350121 ()
  • 10381780065159 ()

  • 3.5 mm dia x 15.2 mm L; 12 mm thread
28135012

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
28135010
Not in Commercial Distribution

  • M248281350101 ()
  • 10381780065142 ()

  • 3.5 mm dia x 13.2 mm L; 10 mm thread
28135010

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
The Viper cortical titanium screw, which is placed proximally.
Ascension Orthopedics, Inc.
2813508
Not in Commercial Distribution

  • M24828135081 ()
  • 10381780065135 ()

  • 3.5mm dia x 11.2 mm L; 8 mm thread
2813508

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
is a sponge for wound dressing, prepping, and scrubbing.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433441 ()
  • 00850014433444 ()
  • 20850014433448 ()

  • Height: 4 Inch
  • Length: 4 Inch
DU1204

  • Non-woven gauze pad, non-sterile
Mixing Tip/ Intraoral Tip is the mixing and application device to be applied with AH Plus Jet and is available seperately
Dentsply De Trey GmbH
60620116
In Commercial Distribution

  • D01060620110 ()
  • D01060620111 ()

  • Length: 5.2 Centimeter
60620116

  • Endodontic filling/sealing material
The cart (trolley) is a Non-Metallic 3 shelf mobile equipment cart, is used for transporting the Heidelberg pH Capsule systems devices.
Heidelberg Medical Inc
Heidelberg System Equipment Cart
In Commercial Distribution

  • B989EC1150 ()
EC115

  • Utility trolley
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. 30 Part B Carpules, bagged.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 67-028 N
In Commercial Distribution

  • D801SP67028N1 ()
67-028

  • Dentine adhesive
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3570LS
In Commercial Distribution

  • M269PSS3570LS1 ()
  • 10381780121244 ()

  • 2.864 in L x .138 in dia
PSS3570LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3565LS
In Commercial Distribution

  • M269PSS3565LS1 ()
  • 10381780121237 ()

  • 2.667 in L x .138 in dia
PSS3565LS

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3560LS
In Commercial Distribution

  • M269PSS3560LS1 ()
  • 10381780121220 ()

  • 2.470 in L x .138 in dia
PSS3560LS

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