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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Screw Driver for Bone Screws
Safetyfix Medical Technologies
Driver
In Commercial Distribution

  • 00853785008040 ()
Driver

  • Surgical screwdriver, reusable
SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable
MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet
SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable
SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual
Square Cage Driver (AO connector)
CAPTIVA SPINE, INC.
CSE06-R-0500-86
In Commercial Distribution

  • 00850065741253 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet
Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet
Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet
Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver
No Description
Wheelhouse Medical
WM01-0112
In Commercial Distribution

  • 00850058050102 ()


  • Surgical screwdriver, reusable
No Description
Wheelhouse Medical
WM01-0086
In Commercial Distribution

  • 00850058050072 ()


  • Surgical screwdriver, reusable
FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
INTEGRATED MEDCRAFT LLC
1011-23000CB
In Commercial Distribution

  • 00850056748018 ()


  • Intraosseous infusion kit
Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Ambu A/S
512001000
In Commercial Distribution

  • 05707480136988 ()
  • 05707480136971 ()
  • 05707480136964 ()

  • Lumen/Inner Diameter: 2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 350 Millimeter
512001000

  • Flexible video otorhinolaryngoscope, single-use
UARS Disposable Sensors, Sleepmate Min. purchase 10 pcs. = 1 pack Sleepmate no. 1601
Ambu A/S
816400-000/10
In Commercial Distribution

  • 05707480041909 ()
  • 05707480134014 ()
816400-000/10

  • Polysomnograph
HAND DRIVER
POLARISAR, INC.
Revision 01
In Commercial Distribution

  • 00850046497087 ()
30-0022

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Driver, T6 Torx X15TN SS
Accufix Surgical, Inc.
AJDH-T6-X15TN
In Commercial Distribution

  • 00850044114009 ()
AJDH-T6-X15TN

  • Surgical screwdriver, reusable
DriverClip NBM. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Resilient slide lock. Single use.
Implantwise LLC
NBM.
In Commercial Distribution

  • 00850043387367 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip S. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Single use only.
Implantwise LLC
S
In Commercial Distribution

  • 00850043387350 ()


  • Surgical instrument interim-placement holder, single-use
DriverClip Universal. Clip that goes through any orifice of a dental implant screwdriver with a floss tether attachment. Single use only.
Implantwise LLC
Universal
In Commercial Distribution

  • 00850043387343 ()


  • Surgical instrument interim-placement holder, single-use
Mini Clamp Driver
Proprio, Inc.
1200019
In Commercial Distribution

  • 00850042604229 ()
1200019

  • Assistive gripping/twisting tool, reusable
No Description
Jeil Medical Corporation
111-440
In Commercial Distribution

  • 08800089452712 ()


  • Surgical mallet
3.5MM QC CAPTIVE SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
Y9339051
In Commercial Distribution

  • 00721902605383 ()


  • Surgical screwdriver, reusable
ZEPHIR 8796324 QUAD DRVE SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8796324
In Commercial Distribution

  • 00721902602344 ()


  • Surgical screwdriver, reusable
ZEPHIR 8796034 ZPHR SQ REMOVAL DRVER
MEDTRONIC SOFAMOR DANEK, INC.
8796034
In Commercial Distribution

  • 00721902602337 ()


  • Surgical screwdriver, reusable
LOCKSCREW DRIVER 38MM-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0802484
In Commercial Distribution

  • 00721902577734 ()


  • Orthopaedic implant driver
BONE SCREW DRIVER 38MM-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0802482
In Commercial Distribution

  • 00721902577727 ()


  • Orthopaedic implant driver
LIBERTY QC OPEN SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X812-911
In Commercial Distribution

  • 00721902562891 ()


  • Orthopaedic implant driver
CLAMP DRIVER 961-584 ACC SURETRAK2
MEDTRONIC NAVIGATION, INC.
961-584
In Commercial Distribution

  • 00721902467660 ()


  • Multi-purpose stereotactic surgery system
DRIVER X1201019 EXTENDED 4 INCH 3D
MEDTRONIC SOFAMOR DANEK, INC.
X1201019
In Commercial Distribution

  • 00721902340789 ()


  • Orthopaedic implant driver
INSTRUMENT 9166130 PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
9166130
In Commercial Distribution

  • 00721902331220 ()


  • Surgical screwdriver, reusable
MODIFIED M8 FIXED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0401013
In Commercial Distribution

  • 00721902298752 ()


  • Orthopaedic implant driver
INSTRUMENT 8670040 SEXTNT CMBNTN PLGDRVR
MEDTRONIC SOFAMOR DANEK, INC.
8670040
In Commercial Distribution

  • 00721902279287 ()


  • Orthopaedic implant driver
CLOSED SCREWDRIVER / RETAINER
MEDTRONIC SOFAMOR DANEK, INC.
X1001008
In Commercial Distribution

  • 00721902264214 ()


  • Orthopaedic implant driver
SHAFT X0901009 DRIVER 3.3MM
MEDTRONIC SOFAMOR DANEK, INC.
X0901009
In Commercial Distribution

  • 00721902246111 ()


  • Orthopaedic implant driver
SLEEVE X0901008 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0901008
In Commercial Distribution

  • 00721902246104 ()


  • Orthopaedic implant driver
INSTRUMENT 8968006 3 5MM HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8968006
In Commercial Distribution

  • 00721902230769 ()

  • 3.5mm


  • Orthopaedic implant driver
AWL / STAPLE DRIVER W/ EXT TIP
MEDTRONIC SOFAMOR DANEK, INC.
X0901030
In Commercial Distribution

  • 00721902213939 ()


  • Bone awl, reusable
DRIVER 2300000LO POWEREASE LOANER
MEDTRONIC SOFAMOR DANEK, INC.
2300000LO
In Commercial Distribution

  • 00643169882812 ()


  • Surgical screwdriver, reusable
DRIVER EX0816077 SET SCW RTNG 4.75 T-HDL
MEDTRONIC SOFAMOR DANEK, INC.
EX0816077
In Commercial Distribution

  • 00643169865310 ()


  • General internal orthopaedic fixation system implantation kit
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