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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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LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265200IVD
In Commercial Distribution

  • 10888234400349 ()
265200IVD

  • HLA class II antigen tissue typing IVD, kit, multiplex
LIFECODES LSA Class I is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265100IVD
In Commercial Distribution

  • 10888234400332 ()
265100IVD

  • HLA class I antigen tissue typing IVD, kit, multiplex
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The mesh ultrasonic nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.
Gvm - US Inc
NB-JLN-MB005
Not in Commercial Distribution

  • 00850022699115 ()
A18GBH1098

  • Ultrasonic nebulizing system
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
VELA OPERATIONS SINGAPORE PTE. LTD.
300216
In Commercial Distribution

  • 08885013953664 ()
300216

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
AMSure® Enteral Feeding Pump Spike Set Secure Lock Tip, Spike is Compatible with Nestlé's ULTRAPAK® Nutrition Bag, SPIKERIGHT™, For Enteral Feeding Only
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411005507 ()
  • 10704411005506 ()
ESR500

  • Enteral feeding kit, adult/paediatric, non-sterile
AH Plus Jet Starter Kit is a 2 component paste/paste root canal sealer based on epoxy-amine resin. AH Plus Jet is received in a syringe (D010K3001600) delivery for homogeneous mixing of both pastes. With its supporting accessories (Mixing/Intraoral Tips, Mixing Pad and Organizer Tray) it can be classified as a convenience kit.
Dentsply De Trey GmbH
60620115
In Commercial Distribution

  • D010606201151 ()

  • Weight: 15 Gram
  • Paste
60620115

  • Endodontic filling/sealing material
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
7.5 mm x 180 mm
In Commercial Distribution

  • 10855068008720 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 180 Millimeter
CRS-075-180-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
7.5 mm x 170 mm
In Commercial Distribution

  • 10855068008713 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 170 Millimeter
CRS-075-170-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Curvafix Inc
7.5 mm x 160 mm
In Commercial Distribution

  • 10855068008706 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 160 Millimeter
CRS-075-160-01

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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