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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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Longitudinal Frame with Push Button
BOSS INSTRUMENTS, LTD., INC.
SS1100
In Commercial Distribution

  • 00888515258525 ()
SS1100

  • Surgical retraction system mounting frame, reusable
3.5mm Hexagonal Screwdriver with handle
Shoulder Options, Inc.
SO02-3075
In Commercial Distribution

  • 00815482020893 ()

  • 3.5mm Hex
SO02-3075

  • Surgical screwdriver, reusable
2.5mm Hexagonal Screwdriver with handle
Shoulder Options, Inc.
SO02-3070
In Commercial Distribution

  • 00815482020886 ()

  • 2.5mm Hex
SO02-3070

  • Surgical screwdriver, reusable
Depth Gauge 60mm with Cap
Surgical Direct, Inc.
SD14919-1001
In Commercial Distribution

  • B382SD1491910010 ()
SD14919-1001

  • Surgical depth gauge, single-use
Rod Introducer, Knob with Stopper
SPINECRAFT, LLC
6100-12KS
In Commercial Distribution

  • M824610012KS1 ()
6100-12KS

  • General internal orthopaedic fixation system implantation kit
Combination Screwdriver, with Solid Pin
SPINECRAFT, LLC
4010-13-SP
In Commercial Distribution

  • M824401013SP1 ()
4010-13-SP

  • General internal orthopaedic fixation system implantation kit
Stopcock with On/Off Valve
Surgical Direct, Inc.
SD91192000
In Commercial Distribution

  • B382SD911920000 ()
SD91192000

  • Endoscope sheath, reusable
DUALWAVE WITH FOOT PEDAL SET
ARTHREX, INC.
AR-6480-SF
In Commercial Distribution

  • 00888867118133 ()
  • M150AR6480SF0 ()
AR-6480-SF

  • Arthroscopic surgical procedure kit, non-medicated, single-use
Surgical Tray with Instrument set
OSSEOLINK USA LLC
STRAY
In Commercial Distribution

  • 00816273020740 ()


  • Dental implant/prosthesis surgical procedure kit
Parallel Drill Guide with Extensions
ARTHREX, INC.
AR-7007
In Commercial Distribution

  • 00888867207172 ()
AR-7007

  • Surgical drill guide, reusable
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