Company Name Brand Name GMDN Term 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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microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform
FHC, INC.
44975Z-00267
In Commercial Distribution

  • 10873263002671 ()
  • 00873263002674 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
44975Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Platform
FHC, INC.
44975L-00263
In Commercial Distribution

  • 10873263002633 ()
  • 00873263002636 ()

  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 205.72 Millimeter
44975L

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, R.ZAP, Platform
FHC, INC.
44970R-00259
In Commercial Distribution

  • 10873263002596 ()
  • 00873263002599 ()

  • Length: 205.72 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 10 Millimeter
44970R

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685Z-00254
In Commercial Distribution

  • 10873263002541 ()
  • 00873263002544 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34685Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, single, D.ZAP(L), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685L-00252
In Commercial Distribution

  • 10873263002527 ()
  • 00873263002520 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
34685L

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, single, 1 Meg for use with Frame and STar or MT Drive
FHC, INC.
34680R-00250
In Commercial Distribution

  • 10873263002503 ()
  • 00873263002506 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
34680R

  • Depth electrode
microTargeting Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive
FHC, INC.
22675L-00244
In Commercial Distribution

  • 10873263002442 ()
  • 00873263002445 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
22675L

  • Depth electrode
microTargeting Array Electrode, sterile, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
22670R-00242
In Commercial Distribution

  • 10873263002428 ()
  • 00873263002421 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22670R

  • Depth electrode
microTargeting™ Platform Platinum 5X Sterile
FHC, INC.
45375Z-00800
In Commercial Distribution

  • 10873263008000 ()
  • 00873263008003 ()

  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Length: 212.72 Millimeter
  • Length: 3 Millimeter
45375Z

  • Depth electrode
microTargeting™ Platform Electrodes 5x Sterile
FHC, INC.
44375Z-00798
In Commercial Distribution

  • 10873263007980 ()
  • 00873263007983 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
44375Z

  • Depth electrode
microTargeting™ Single Frame Platinum 5X Sterile
FHC, INC.
35385Z-00796
In Commercial Distribution

  • 10873263007966 ()
  • 00873263007969 ()

  • Length: 3 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
35385Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 5X Sterile
FHC, INC.
34385Z-00794
In Commercial Distribution

  • 10873263007942 ()
  • 00873263007945 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
34385Z

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWLN(AR)(DU1)-00707
In Commercial Distribution

  • 10873263007072 ()
  • 00873263007075 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.5 Millimeter
  • Length: 286.5 Millimeter
MTDWLN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DU1)-00706
In Commercial Distribution

  • 10873263007065 ()
  • 00873263007068 ()

  • Length: 271.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 286.5 Millimeter
  • Impedance: Megaohms
MTDWZN(AR)(DU1)

  • Depth electrode
microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode
microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive
FHC, INC.
22675Z-00246
In Commercial Distribution

  • 10873263002466 ()
  • 00873263002469 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
22675Z

  • Depth electrode
microTargeting™ Array Frame Platinum 5X Sterile
FHC, INC.
25375Z-00792
In Commercial Distribution

  • 10873263007928 ()
  • 00873263007921 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
25375Z

  • Depth electrode
microTargeting™ Array Electrodes 5x Sterile
FHC, INC.
22375Z-00790
In Commercial Distribution

  • 10873263007904 ()
  • 00873263007907 ()

  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
22375Z

  • Depth electrode
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
In Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
In Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
icotec Instrument Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block
easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD SERONO, INC.
U1222102
In Commercial Distribution

  • 04054839025860 ()


  • Cartridge-accepting autoinjector, electronic
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Multiple respiratory virus antigen IVD, kit, multiplex
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system
Graft Packing Block, 18mm
SEASPINE ORTHOPEDICS CORPORATION
95-6091
In Commercial Distribution

  • 10889981097783 ()

  • 18mm
95-6091

  • Bone graft packing block
Zuma-C Universal Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7092
In Commercial Distribution

  • 10889981120733 ()

  • N/A
95-7092

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
95-7091
In Commercial Distribution

  • 10889981100223 ()

  • N/A
95-7091

  • Bone graft packing block
Graft Packing Block, 38mm x 26mm
SEASPINE ORTHOPEDICS CORPORATION
95-5193
In Commercial Distribution

  • 10889981120627 ()

  • 38mm x 26mm
95-5193

  • Bone graft packing block
Graft Packing Block, 32mm x 25mm
SEASPINE ORTHOPEDICS CORPORATION
95-5192
In Commercial Distribution

  • 10889981096533 ()

  • 32mm x 25mm
95-5192

  • Bone graft packing block
Graft Packing Block, 26mm x 24mm
SEASPINE ORTHOPEDICS CORPORATION
95-5191
In Commercial Distribution

  • 10889981096526 ()

  • 26mm x 24mm
95-5191

  • Bone graft packing block
PACKING BLOCK FOR ZERO-P VA IMPLANTS
SYNTHES (U.S.A.) LP
03.647.984
In Commercial Distribution

  • 07611819404502 ()
  • H981036479840 ()
  • 10705034720838 ()
03647984

  • Bone graft packing block
Graft Packer (Custom Finish)
Zoll-Dental
GP-SP
In Commercial Distribution

  • 00840105205647 ()


  • Bone graft packing block
Graft Packer 6.0mm/8.0mm Smooth
Zoll-Dental
GP-6.0/8.0SM
In Commercial Distribution

  • 00840105205623 ()


  • Bone graft packing block
Graft Packer 6.0mm/8.0mm Serrated
Zoll-Dental
GP-6.0/8.0SER
In Commercial Distribution

  • 00840105205616 ()


  • Bone graft packing block
Graft Packer 5.0mm/5.5mm Smooth
Zoll-Dental
GP-5.0/5.5SM
In Commercial Distribution

  • 00840105205609 ()


  • Bone graft packing block
Graft Packer 5.0mm/5.5mm Serrated
Zoll-Dental
GP-5.0/5.5SER
In Commercial Distribution

  • 00840105205593 ()


  • Bone graft packing block
Graft Packer 4.2mm/4.8mm Smooth
Zoll-Dental
GP-4.2/4.8SM
In Commercial Distribution

  • 00840105205586 ()


  • Bone graft packing block
Graft Packer 4.2mm/4.8mm Serrated
Zoll-Dental
GP-4.2/4.8SER
In Commercial Distribution

  • 00840105205579 ()


  • Bone graft packing block
Graft Packer 3.2mm/3.8mm Smooth
Zoll-Dental
GP-3.2/3.8SM
In Commercial Distribution

  • 00840105205562 ()


  • Bone graft packing block
Graft Packer 3.2mm/3.8mm Serrated
Zoll-Dental
GP-3.2/3.8SER
In Commercial Distribution

  • 00840105205555 ()


  • Bone graft packing block
Graft Packer 1.8mm/2.8mm Smooth
Zoll-Dental
GP-1.8/2.8SM
In Commercial Distribution

  • 00840105205548 ()


  • Bone graft packing block
Graft Packer 1.8mm/2.8mm Serrated
Zoll-Dental
GP-1.8/2.8SER
In Commercial Distribution

  • 00840105205531 ()


  • Bone graft packing block
Graft Packer 1.5mm/1.8mm Smooth
Zoll-Dental
GP-1.5/1.8SM
In Commercial Distribution

  • 00840105205524 ()


  • Bone graft packing block
Graft Packer 1.5mm/1.8mm Serrated
Zoll-Dental
GP-1.5/1.8SER
In Commercial Distribution

  • 00840105205517 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7223
In Commercial Distribution

  • 00840105220503 ()


  • Bone graft packing block
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