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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 Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the Alumi-Hand is ready to go. Made of aluminum, the Alumi-Hand is Lead-Free, Latex-Free, and X-ray compatible. Box or 8
INSTRUMENT SPECIALISTS, INC.
Extra Large
In Commercial Distribution

  • 00810045920023 ()
761-8

  • Limb/torso/head restraint, single-use
The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable. The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1029030 ()
U1 029 03

  • Electromagnetic surgical navigation device tracking system
The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg/1.2mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
ABBVIE INC.
19558594
In Commercial Distribution

  • 48054083023968 ()

  • Width: 41 Millimeter
  • Length: 85 Millimeter
  • Height: 22.5 Millimeter
19558594

  • Subcutaneous self-injection aid
The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
ABBVIE INC.
19558595
In Commercial Distribution

  • 48054083023234 ()

  • Width: 41 Millimeter
  • Length: 85 Millimeter
  • Height: 22.5 Millimeter


  • Subcutaneous self-injection aid
Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberate the components in area where the access, due to soft tissues, is limited. When the instrument is placed at the femoral distal trochlea groove, it is ideal for pulling off the femoral implant. This is a reusable device.
MPS Micro Precision Systems AG
T14587
In Commercial Distribution

  • 07640187910490 ()
T14587

  • Orthopaedic inorganic implant inserter/extractor, reusable
REPOSITIONING SLEEVE
ST. JUDE MEDICAL, INC.
406503
In Commercial Distribution

  • 05414734030052 ()
  • 15414734030059 ()

  • Length: 60 Centimeter
406503

  • Cardiovascular catheter sheath
This is sold as part of the 11-Unit Packages for Lucitone 199 and Hy-Pro Lucitone. It is not sold separately.
Dentsply International Inc.
Liquid
In Commercial Distribution

  • D0016843050 ()

  • Total Volume: 120 Milliliter


  • Dental appliance fabrication material, resin
Fibered Light. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Light (684406) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019844100 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Fibered Dark. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Dark (684175) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution

  • D0019841660 ()

  • Weight: 231 Gram


  • Dental appliance fabrication material, resin
Light Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution

  • D0019800540 ()

  • Weight: 21 Gram


  • Dental appliance fabrication material, resin
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