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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A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6131
In Commercial Distribution

  • 05060472462473 ()
PL.6131

  • Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical
Handpiece for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
30327000
Not in Commercial Distribution

  • J021303270000 ()
  • J021303270001 ()


  • Dental ultrasonic surgical system handpiece
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0592
In Commercial Distribution

  • 30607915120499 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic
Sub Q infusion set. Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
Unomedical A/S
71-060-2738
Not in Commercial Distribution

  • 05705244004672 ()
  • 05705244009868 ()
  • 05705244004689 ()

  • Length: 60 Centimeter
  • Depth: 8 Millimeter
  • Angle: 90 degree


  • Electric infusion pump administration set, single-use
Rabbit antisera. Ready-To-Use.
Ssi Diagnostica A/S
53827
Not in Commercial Distribution

  • 05713106538272 ()
53827

  • Multiple Salmonella species culture isolate antigen IVD, antibody
BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab, sterile polyurethane-tipped collection swab, Q? Swab Diluent tube
BECTON, DICKINSON AND COMPANY
441357
In Commercial Distribution

  • 30382904413577 ()
  • 00382904413576 ()
441357

  • Urogenital specimen collection kit IVD, clinical
A surgical and therapeutic device intended for a variety of soft-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Epic Q Laser System
In Commercial Distribution

  • 00647529004357 ()
7410008

  • Dental diode laser system
6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded, multi-layered. Suitable for single crowns and/or bridges consisting of up to 3 units. Bending strength: 600 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Q³ Multi-Shade C-Dark
Not in Commercial Distribution

  • EDMC34923000470 ()

  • Height: 20 Millimeter
3492300047

  • Dental appliance fabrication material, ceramic
6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded, multi-layered. Suitable for single crowns and/or bridges consisting of up to 3 units. Bending strength: 600 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Q³ Multi-Shade C-Dark
Not in Commercial Distribution

  • EDMC34923000460 ()

  • Height: 16 Millimeter
3492300046

  • Dental appliance fabrication material, ceramic
6Y-PSZ zirconium dioxide, pre-sintered white-fired condition. Ultra-high translucent, pre-shaded, multi-layered. Suitable for single crowns and/or bridges consisting of up to 3 units. Bending strength: 600 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Q³ Multi-Shade C-Light
Not in Commercial Distribution

  • EDMC34923000450 ()

  • Height: 20 Millimeter
3492300045

  • Dental appliance fabrication material, ceramic
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