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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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IMPLANT DIRECT SYBRON MANUFACTURING LLC
PEEK-2.5
In Commercial Distribution

  • 10841307119449 ()
  • 00841307119442 ()
PEEK-2.5

  • Surgical screwdriver, reusable
Resilient precision attachment. Kit contains: Three large post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each Pilot drill, countersink bur, core cutter bur and seating tool.
STERNGOLD DENTAL LLC
811412
In Commercial Distribution

  • 00841549101823 ()


  • Resilient dental precision attachment
Resilient precision attachment. Kit Contains: Three small post females, (2-0°& 1-11°) Males, 3 sets of 5,(two each of white and black and one orange) 2 metal jackets, 2 Alignment handles, 2 blockout spacers, 1 of each pilot drill, countersink bur, core cutter bur and seating tool
STERNGOLD DENTAL LLC
811410
In Commercial Distribution

  • 00841549101809 ()


  • Resilient dental precision attachment
This part contains:Five Large post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 2 blockout spacers, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.
STERNGOLD DENTAL LLC
811402
Not in Commercial Distribution

  • 00841549101755 ()


  • Resilient dental precision attachment
This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.
STERNGOLD DENTAL LLC
811400
In Commercial Distribution

  • 00841549101748 ()


  • Resilient dental precision attachment
The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Controller (6.0/W10 loT)
In Commercial Distribution

  • 09349458004859 ()
S21.4621

  • Microscope slide stainer IVD
The Randox RX daytona plus without ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4041
In Commercial Distribution

  • 05055273207781 ()
RX4041

  • Multiple clinical chemistry analyser IVD, laboratory
The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software.
RANDOX LABORATORIES LIMITED
RX4040
In Commercial Distribution

  • 05055273207774 ()
RX4040

  • Multiple clinical chemistry analyser IVD, laboratory
The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single Master Pool Tube (MPT), which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and MPT composition. The Procleix Xpress System is intended to create whole blood lysates and/or pools of whole blood lysates for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single MPT. The pooled or individual lysates may be used for further testing in Procleix systems. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 4.0
In Commercial Distribution

  • 00859882007948 ()
742248

  • Nucleic acid sample preparation instrument IVD
The Procleix Xpress System v2.1 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 2.1
In Commercial Distribution

  • 00859882007764 ()
741632

  • Pipetting system IVD
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