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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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Redi Splint 2, Small, Olive Drab, Flat. Moldable first aid splint
FARETEC, INC.
Redi Splint 2
In Commercial Distribution

  • B54112113130 ()
1211313

  • First aid limb splint, mouldable, single-use
No Description
Laborie Medical Technologies Canada ULC
9021P6022
In Commercial Distribution

  • 20627825007256 ()
  • 10627825007259 ()
  • 30627825007253 ()


  • Urological pressure monitoring tubing set
Diamond-coated tip for the finishing of the access cavity and the removal of dentinal
EDGE ENDO LLC
ET18D
In Commercial Distribution

  • 00818365020157 ()


  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
No Description
Vista Dental
90635
In Commercial Distribution

  • 00818207020734 ()


  • Dentine bonding agent/set
COUNTER TORQUE
SpineArt SA
ELL-IN 02 11-N
In Commercial Distribution

  • 07640151089610 ()
ELL-IN 02 11-N

  • Orthopaedic counter-torque/rod-pushing instrument
K-WIRE BLUNT - NITINOL
SpineArt SA
MIS-IN 02 12-S
In Commercial Distribution

  • 07640151087135 ()
MIS-IN 02 12-S

  • Orthopaedic bone wire
STRAIGHT RATCHETING HANDLE / XL
SpineArt SA
HAN-SI RA SX-N
In Commercial Distribution

  • 07640151086985 ()
HAN-SI RA SX-N

  • Surgical instrument handle, non-torque-limiting
TROCAR 3 IN 1 - Ti STICK
SpineArt SA
MIS-IN 03 16-N
In Commercial Distribution

  • 07640151086954 ()
MIS-IN 03 16-N

  • Surgical instrument handle, non-torque-limiting
AO HANDLE
SpineArt SA
HAN-SI AO 08-N
In Commercial Distribution

  • 07640151086428 ()
HAN-SI AO 08-N

  • Surgical instrument handle, non-torque-limiting
J-HOOK
SpineArt SA
ELL-IN 00 40-N
In Commercial Distribution

  • 07640151086206 ()
ELL-IN 00 40-N

  • Orthopaedic inorganic implant inserter/extractor, reusable
ROD PUSHER
SpineArt SA
ELL-IN 00 39-N
In Commercial Distribution

  • 07640151086190 ()
ELL-IN 00 39-N

  • Orthopaedic rod reducer
ROD INSERTER
SpineArt SA
MIS-IN 35 02-N
In Commercial Distribution

  • 07640151082529 ()
MIS-IN 35 02-N

  • Surgical implant/trial-implant/sizer holder, reusable
CENTERING GUIDE
SpineArt SA
MIS-IN 45 00-N
In Commercial Distribution

  • 07640151082475 ()
MIS-IN 45 00-N

  • Surgical instrument handle, non-torque-limiting
QR REDUCER T-HANDLE
SpineArt SA
HAN-SS TY 14-N
In Commercial Distribution

  • 07640151082130 ()
HAN-SS TY 14-N

  • Surgical instrument handle, non-torque-limiting
TAP Ø 7.5 x 30
SpineArt SA
ELL-IN 75 30-N
In Commercial Distribution

  • 07640151082093 ()
ELL-IN 75 30-N

  • Bone tap, reusable
TAP Ø 6.5 x 30
SpineArt SA
ELL-IN 65 30-N
In Commercial Distribution

  • 07640151082086 ()
ELL-IN 65 30-N

  • Bone tap, reusable
TAP Ø 5.5 x 30
SpineArt SA
ELL-IN 55 30-N
In Commercial Distribution

  • 07640151082079 ()
ELL-IN 55 30-N

  • Bone tap, reusable
TAP Ø 4.5 x 30
SpineArt SA
ELL-IN 45 30-N
In Commercial Distribution

  • 07640151082062 ()
ELL-IN 45 30-N

  • Bone tap, reusable
TAP Ø 4 x 30
SpineArt SA
ELL-IN 40 30-N
In Commercial Distribution

  • 07640151082055 ()
ELL-IN 40 30-N

  • Bone tap, reusable
OFFSET ENDTIP
SpineArt SA
ELL-IN 03 08-N
In Commercial Distribution

  • 07640151082048 ()
ELL-IN 03 08-N

  • Orthopaedic surgical distractor, internal
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