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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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No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Pelican Case
In Commercial Distribution

  • 27290114063702 ()
700-000888-00

  • Neurological stereotactic surgery system
Twin Transport Case for the Novoste Beta-Cath System
BEST VASCULAR, INC.
TRC-0002
In Commercial Distribution

  • M097TRC00020 ()
TRC-0002

  • Manual-afterloading brachytherapy system source transfer device transport case/set
Guided Case Planning
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118145998 ()
TGC-0001

  • Dental implant system
A distraction-compression case is a kit, or a set of instruments designed to perform distraction and compression on a bony structure. The instruments within the case are used to: Distract: To pull apart or lengthen two adjacent bony segments. This is often done to restore anatomical alignment, decompress a nerve, or create a space for a bone graft or implant. Compress: To push together two bony segments. This is typically done to stabilize a fracture, achieve a solid fusion, or close a gap between bones. These kits are essential for orthopedic and spinal surgeons to manipulate bones and achieve proper fixation
Bradshaw Medical, Inc.
MRS-103
In Commercial Distribution

  • 00810019931475 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
Advanced Bionics, LLC
305-Q274-004
In Commercial Distribution

  • 00840094415669 ()


  • Cochlear implant/auditory brainstem implant sound processor
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9932
In Commercial Distribution

  • 00848665024319 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9931
In Commercial Distribution

  • 00848665024302 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9930
In Commercial Distribution

  • 00848665024296 ()


  • Instrument tray, reusable
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9929
In Commercial Distribution

  • 00848665024289 ()


  • Instrument tray, reusable
PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software
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