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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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Cross-Fuse® PEEK IBF System - 00191083028842

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1440-13
Not in Commercial Distribution


  • 14mm (W) x 13mm (H) x 40mm (L)
35-1440-13

  • Polymeric spinal interbody fusion cage

Cross-Fuse® PEEK IBF System - 00191083028835

INTERBODY FUSION DEVICE
Pioneer Surgical Technology, Inc.
35-1440-11
Not in Commercial Distribution


  • 14mm (W) x 11mm (H) x 40mm (L)
35-1440-11

  • Polymeric spinal interbody fusion cage

Blood Component Filter Set with Vented Spike and Luer Adapter - 04052682031717

For Administration of Blood and Blood Components During a Therapeutic Plasma Exchange (TPE) or Red Blood Cell Exchange (RBCX) Therapeutic Apheresis Procedure. For use with the AMICUS separator. Sterile Fluid Path.
Fresenius Kabi AG
X6C2170
In Commercial Distribution

  • 04086000100168 ()
  • 04052682031717 ()
  • 14052682031714 ()
X6C2170

  • Blood transfusion set, non-exchange

Leukoconnect - 04052682004308

LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution
Fresenius Kabi AG
4C4300
In Commercial Distribution

  • 14052682004305 ()
  • 04052682004308 ()
  • 00811137010486 ()
4C4300

  • Blood transfer set

Fenwal Red Cell Freezing Pack 2000 mL - 04052682004254

Red Cell Freezing Pack 2000 mL
Fresenius Kabi AG
4R2422
In Commercial Distribution

  • 14052682004251 ()
  • 04052682004254 ()
  • 00811137010769 ()
4R2422

  • Blood/tissue storage/culture container

DIO UF HSA Internal Sub-Merged Implant System - 08806195930090

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
DIO Corporation
UF 5013S
Not in Commercial Distribution


  • Ø5.0X13mm
UF 5013S

  • Screw endosteal dental implant, two-piece

DIO UF HSA Internal Sub-Merged Implant System - 08806195930083

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
DIO Corporation
UF 5011S
Not in Commercial Distribution


  • Ø5.0X11.5mm
UF 5011S

  • Screw endosteal dental implant, two-piece

DIO UF HSA Internal Sub-Merged Implant System - 08806195930076

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
DIO Corporation
UF 5010S
Not in Commercial Distribution


  • Ø5.0X10mm
UF 5010S

  • Screw endosteal dental implant, two-piece

DIO UF HSA Internal Sub-Merged Implant System - 08806195930069

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
DIO Corporation
UF 5008S
Not in Commercial Distribution


  • Ø5.0X8.5mm
UF 5008S

  • Screw endosteal dental implant, two-piece

DIO UF HSA Internal Sub-Merged Implant System - 08806195930052

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
DIO Corporation
UF 5007S
Not in Commercial Distribution


  • Ø5.0X7mm
UF 5007S

  • Screw endosteal dental implant, two-piece
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