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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ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

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

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
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
The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution

  • 00850018836067 ()


  • Gait rehabilitation frame, manual
The ZeroG-Lite system is intended to assist patients with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Lite should never be used to lift and transport patients, and should never be connected to inanimate objects. ZeroG-Lite should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG-Lite training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGL-V3
In Commercial Distribution

  • 00850018836234 ()


  • Gait rehabilitation frame, electric
The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric
PACKING BLOCK FOR ZERO-P VA IMPLANTS
Synthes GmbH
03.647.984
In Commercial Distribution

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

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

  • 00840105205647 ()


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

  • 00840105205623 ()


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

  • 00840105205616 ()


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

  • 00840105205609 ()


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

  • 00840105205593 ()


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

  • 00840105205586 ()


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

  • 00840105205579 ()


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

  • 00840105205562 ()


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

  • 00840105205555 ()


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

  • 00840105205548 ()


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

  • 00840105205531 ()


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

  • 00840105205524 ()


  • Bone graft packing block
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
Graft Packer/Plugger
Zoll-Dental
Z-7222
In Commercial Distribution

  • 00840105220497 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7221
In Commercial Distribution

  • 00840105220480 ()


  • Bone graft packing block
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