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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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Tray
MIZUHO AMERICA, INC.
07-944-44F
In Commercial Distribution

  • 00810009464020 ()


  • Instrument tray, reusable
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
Salvin TG Driver
SALVIN DENTAL SPECIALTIES, LLC
TG
In Commercial Distribution

  • 00841336111530 ()
TG

  • Dental torque wrench
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
9932
In Commercial Distribution

  • 00848665024319 ()


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

  • 00848665024296 ()


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

  • 00848665024302 ()


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

  • 00848665024289 ()


  • Instrument tray, reusable
TiLock PSS Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719G60000 ()
G6000

  • Bone-screw internal spinal fixation system, non-sterile
Standalone System Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719G45130 ()
G4513

  • Instrument tray, reusable
TiLock Instrument Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719G15000 ()
G1500

  • Bone-screw internal spinal fixation system, non-sterile
BREAST CASE PACK
Cardinal Health 200, LLC
SBA53BRPR9
In Commercial Distribution

  • 50195594310989 ()
  • 10195594310981 ()
SBA53BRPR9

  • General surgical procedure kit, non-medicated, single-use
TiLock Implant Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719G10000 ()
G1000

  • Bone-screw internal spinal fixation system, non-sterile
Ancillary Outer Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719ACS10000 ()
ACS1000

  • Bone-screw internal spinal fixation system, non-sterile
END CAP CASE
MEDTRONIC SOFAMOR DANEK, INC.
9050906
In Commercial Distribution

  • 00721902016882 ()


  • Instrument tray, reusable
BREAST CASE PACK
Cardinal Health 200, LLC
SBA53BRPR8
In Commercial Distribution

  • 50195594173478 ()
  • 10195594173470 ()
SBA53BRPR8

  • General surgical procedure kit, non-medicated, single-use
PEDIATRIC CASE PACK
Cardinal Health 200, LLC
SBA41PCUS7
In Commercial Distribution

  • 50195594278838 ()
  • 10195594278830 ()
SBA41PCUS7

  • General surgical procedure kit, medicated
CASE 875-950 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
875-950
In Commercial Distribution

  • 00721902560309 ()


  • Instrument tray, reusable
Modular Outer Case
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719G88010 ()
G8801

  • Bone-screw internal spinal fixation system, non-sterile
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