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
PRO-DEX, INC.
APD-SC-003
In Commercial Distribution

  • 00856482008184 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
05.000.030
In Commercial Distribution

  • 00856482008023 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-BP-001S-1
In Commercial Distribution

  • 00856482008009 ()
  • 10856482008006 ()


  • Disposable battery pack
No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
Ambu aScope 4 RhinoLaryngo Slim Single-use, flexible Rhinolaryngoscope Sterile from package. Insertion cord diameter 3.0 mm, lenght of 300 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Ambu A/S
510001000
In Commercial Distribution

  • 05707480140640 ()
  • 05707480140657 ()
  • 05707480140664 ()

  • Outer Diameter: 3 Millimeter
  • Length: 300 Millimeter
510001000

  • Flexible video otorhinolaryngoscope, single-use
Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Minimum purchase is 10 pcs. = 1 box
Ambu A/S
480300000
Not in Commercial Distribution

  • 05707480137084 ()
  • 05707480137077 ()
  • 05707480137091 ()
480300000

  • General-purpose surgical suction system, vacuum
Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box
Ambu A/S
414001000
Not in Commercial Distribution

  • 05707480133116 ()
  • 05707480133109 ()
  • 05707480133123 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Outer Diameter: 5.8 Millimeter
  • Size 3
  • Length: 600 Millimeter
414001000

  • Flexible video bronchoscope, single-use
Limb Sensor Kit (one limb) Min. purchase is 5 pcs. = 1 set (Sleepmate item 1711)
Ambu A/S
817210-100
In Commercial Distribution

  • 05707480042852 ()
  • 05707480096800 ()
817210-100

  • Polysomnograph
Piezo Crystal Sensor & Band (adult/ped) Double Buckle (Sleepmate item 1310) Min. purchase is 5 pcs. = 1 set
Ambu A/S
813236-100
In Commercial Distribution

  • 05707480041343 ()
813236-100

  • Polysomnograph
BUSHING FOR LEKSELL LOWER GUIDE BUSHING FOR 2.4MM DRILL/DRIVER, 83MM LENGTH
PMT CORPORATION
2103-206
In Commercial Distribution

  • 00650551148821 ()


  • Neurological stereotactic surgery system
SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.1MM DRILL
PMT CORPORATION
2103-204
In Commercial Distribution

  • 00650551148784 ()


  • Neurological stereotactic surgery system
BRAINLAB/VERTEK BUSHING FOR 2.4MM DRILL/DRIVER, 70MM LENGTH
PMT CORPORATION
2103-203
In Commercial Distribution

  • 00650551148623 ()


  • Neurological stereotactic surgery system
SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.4MM DRILL
PMT CORPORATION
2103-202
In Commercial Distribution

  • 00650551148616 ()


  • Neurological stereotactic surgery system
Cannulated Ratchet Handle
Treace Medical Concepts, Inc.
1405-2253
In Commercial Distribution

  • 00853114006747 ()


  • Surgical screwdriver, reusable
AO Driver Cannulated
Treace Medical Concepts, Inc.
1405-2241
In Commercial Distribution

  • 00853114006730 ()


  • Surgical screwdriver, reusable
Snap-Off Screwdriver
Treace Medical Concepts, Inc.
1405-2235
In Commercial Distribution

  • 00853114006723 ()


  • Surgical screwdriver, reusable
AO Driver
Treace Medical Concepts, Inc.
1405-2222
In Commercial Distribution

  • 00853114006679 ()


  • Surgical screwdriver, reusable
non-cannulated driver assembly
Treace Medical Concepts, Inc.
1405-2215
In Commercial Distribution

  • 00853114006662 ()


  • Surgical screwdriver, reusable
AO hexalobular tip cannulated
Treace Medical Concepts, Inc.
1405-2205
In Commercial Distribution

  • 00853114006648 ()


  • Surgical screwdriver, reusable
AO hexalobular tip cannulated
Treace Medical Concepts, Inc.
1405-2204
In Commercial Distribution

  • 00853114006631 ()


  • Surgical screwdriver, reusable
AO hexalobular tip
Treace Medical Concepts, Inc.
1405-2202
In Commercial Distribution

  • 00853114006624 ()


  • Surgical screwdriver, reusable
Driver
Treace Medical Concepts, Inc.
1405-2188
In Commercial Distribution

  • 00853114006594 ()


  • Surgical screwdriver, reusable
Placement Pin
ZUGA MEDICAL, INC.
PPT-000-000
In Commercial Distribution

  • 00853095004749 ()


  • Surgical screwdriver, reusable
Hex Driver
THOMPSON SURGICAL INSTRUMENTS, INC.
10060020
In Commercial Distribution

  • 00851267006980 ()


  • Surgical retraction system, reusable
Pneumatic Footswitch
Buffalo Filter
FS10004
Not in Commercial Distribution

  • 00851136002969 ()


  • Foot-switch, pneumatic
SEEG DEPTH ANCHOR BOLT DRIVER WITH MEDIUM WELL SOCKET FOR 2.4MM DRILL
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551147503 ()


  • Neurological stereotactic surgery system
BUSHING FOR 2.4MM DRIVER FOR NEUROMATE
PMT CORPORATION
2103-183
In Commercial Distribution

  • 00650551147480 ()


  • Neurological stereotactic surgery system
RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
In Commercial Distribution

  • 00650551146391 ()
2103-125

  • Neurological stereotactic surgery system
VERTEK BUSHING FOR 2.4MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-154
In Commercial Distribution

  • 00650551137580 ()


  • Neurological stereotactic surgery system
VERTEK BUSHING FOR 2.1MM DRILL/DRIVER W/THUMBSCREW
PMT CORPORATION
2103-153
In Commercial Distribution

  • 00650551137573 ()


  • Neurological stereotactic surgery system
No Description
JACE MEDICAL, LLC
215.010.15
In Commercial Distribution

  • 00851599007914 ()


  • Surgical screwdriver, reusable
No Description
JACE MEDICAL, LLC
201.050.00
Not in Commercial Distribution

  • 00851599007679 ()


  • Surgical screwdriver, reusable
No Description
JACE MEDICAL, LLC
201.047.15
In Commercial Distribution

  • 00851599007655 ()


  • Surgical screwdriver, reusable
No Description
JACE MEDICAL, LLC
201.047.00
Not in Commercial Distribution

  • 00851599007631 ()


  • Surgical instrument handle, torque-limiting
No Description
JACE MEDICAL, LLC
201.033.10
Not in Commercial Distribution

  • 00851599007617 ()


  • Surgical screwdriver, reusable
No Description
JACE MEDICAL, LLC
201.047.06
Not in Commercial Distribution

  • 00851599007495 ()


  • Orthopaedic implant driver
No Description
JACE MEDICAL, LLC
201.033.00
Not in Commercial Distribution

  • 00851599007419 ()


  • Orthopaedic implant driver
Nut and Bolt Caddy Tray
Metalogix
900129-F
In Commercial Distribution

  • 00854641008129 ()

  • Depth: 1.4 Inch
  • Height: 7.7 Inch
  • Width: 11.1 Inch


  • External orthopaedic fixation system, reusable
Slotted 90° Tubular Wrench x 10mm
Metalogix
900104
In Commercial Distribution

  • 00854641008112 ()

  • Slotted 90°
  • Diameter: 10mm
  • Length: 3.89 Inch


  • External orthopaedic fixation system, reusable
General Tray
Metalogix
900127-F
In Commercial Distribution

  • 00854641008099 ()

  • Height: 10.1 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
J/N-Plate Tray
Metalogix
900125-F
In Commercial Distribution

  • 00854641008075 ()

  • Height: 9.6 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable
C/Footplate Tray
Metalogix
900124-F
In Commercial Distribution

  • 00854641008068 ()

  • Height: 10.1 Inch
  • Width: 10.3 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
Implant Tray
Metalogix
900123-F
In Commercial Distribution

  • 00854641008051 ()

  • Width: 10.3 Inch
  • Height: 5.8 Inch
  • Length: 20.9 Inch


  • External orthopaedic fixation system, reusable
Standard Wrench x 10mm
Metalogix
900106
In Commercial Distribution

  • 00854641008044 ()

  • Standard
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Open End/Swivel End Wrench x 10mm
Metalogix
900105
In Commercial Distribution

  • 00854641008037 ()

  • Open End/Swivel End
  • Diameter: 10mm


  • External orthopaedic fixation system, reusable
Wire Tensioner x Ratcheting
Metalogix
900100
In Commercial Distribution

  • 00854641008020 ()


  • External orthopaedic fixation system, reusable
T-Handle Wrench x AO
Metalogix
900103
In Commercial Distribution

  • 00854641008013 ()


  • External orthopaedic fixation system, reusable
Trocar & Sheath 4-6mm
Metalogix
100404
In Commercial Distribution

  • 00854641008006 ()

  • 4-6mm


  • External orthopaedic fixation system, reusable
No Description
Unique Surgical
Ball Joint, Bayonet Connector
In Commercial Distribution

  • 00854515008538 ()


  • Drilling power tool attachment, basic
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