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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SPS AWL, 12MM
ALPHATEC SPINE, INC.
CI-11762
In Commercial Distribution

  • 00840180536308 ()


  • Bone awl, reusable
Insignia 14mm Awl AO
ALPHATEC SPINE, INC.
CI-11707
In Commercial Distribution

  • 00840180533659 ()


  • Bone awl, reusable
Cervical Standalone Angled Awl Reverse Spring
ALPHATEC SPINE, INC.
CI-11698
In Commercial Distribution

  • 00840180533628 ()


  • Bone awl, reusable
4.5mm AWL TAP – LONG AWL, BEVEL
ALPHATEC SPINE, INC.
CI-11597-045-20
In Commercial Distribution

  • 00840180531150 ()


  • Bone awl, reusable
4.5mm AWL TAP – LONG AWL, DIAMOND
ALPHATEC SPINE, INC.
CI-11597-045-10
In Commercial Distribution

  • 00840180531143 ()


  • Bone awl, reusable
AWL TAP DEPTH INDICATOR DILATOR
ALPHATEC SPINE, INC.
CI-11597-500
In Commercial Distribution

  • 00840180530740 ()


  • Bone awl, reusable
AWL TAP HANDLE, THUMBWHEEL ASSEMBLY
ALPHATEC SPINE, INC.
CI-11597-200
In Commercial Distribution

  • 00840180530702 ()


  • Bone awl, reusable
AWL TAP HANDLE, TWO PIECE STYLET WIRE, BEVEL
ALPHATEC SPINE, INC.
CI-11597-300-20
In Commercial Distribution

  • 00840180530696 ()


  • Bone awl, reusable
AWL TAP HANDLE, TWO PIECE STYLET WIRE, DIAMOND
ALPHATEC SPINE, INC.
CI-11597-300-10
In Commercial Distribution

  • 00840180530689 ()


  • Bone awl, reusable
AWL TAP HANDLE, TWO PIECE STYLET
ALPHATEC SPINE, INC.
CI-11597-100
In Commercial Distribution

  • 00840180530528 ()


  • Bone awl, reusable
Insignia Caspar Awl
ALPHATEC SPINE, INC.
CI-11620
In Commercial Distribution

  • 00840180529041 ()


  • Bone awl, reusable
Invictus 7.5mm Blunt Awl Tap
ALPHATEC SPINE, INC.
CI-11537-75
In Commercial Distribution

  • 00840180529010 ()


  • Bone awl, reusable
Invictus 5.5mm Blunt Awl Tap
ALPHATEC SPINE, INC.
CI-11537-55
In Commercial Distribution

  • 00840180528990 ()


  • Bone awl, reusable
Invictus 4.5mm Blunt Awl Tap
ALPHATEC SPINE, INC.
CI-11537-45
In Commercial Distribution

  • 00840180528983 ()


  • Bone awl, reusable
ASPIDA AWL, NO SLEEVE
ALPHATEC SPINE, INC.
CI-11615
In Commercial Distribution

  • 00840180528860 ()


  • Bone awl, reusable
Adjustable Aspida Awl
ALPHATEC SPINE, INC.
CI-11582
In Commercial Distribution

  • 00840180528105 ()


  • Bone awl, reusable
TARGETING NEEDLE - BEVEL
ALPHATEC SPINE, INC.
CI-11530-30
In Commercial Distribution

  • 00840180526088 ()


  • Bone awl, reusable
TARGETING NEEDLE - DIAMOND
ALPHATEC SPINE, INC.
CI-11530-20
In Commercial Distribution

  • 00840180526071 ()


  • Bone awl, reusable
REUSABLE JAMSHIDI - LIGHTWEIGHT HANDLE
ALPHATEC SPINE, INC.
CI-11530-10
In Commercial Distribution

  • 00840180526064 ()


  • Bone awl, reusable
14 mm Stopped Awl Bevel Tip
ALPHATEC SPINE, INC.
CI-11508-02
In Commercial Distribution

  • 00840180525579 ()


  • Bone awl, reusable
14 mm Stopped Awl Diamond Tip
ALPHATEC SPINE, INC.
CI-11508-01
In Commercial Distribution

  • 00840180525562 ()


  • Bone awl, reusable
CANNULATED AWL TAP INNER CANNULA - TROCAR
ALPHATEC SPINE, INC.
CI-11315-200-10
In Commercial Distribution

  • 00840180524428 ()


  • Bone awl, reusable
CANNULATED AWL TAP T HANDLE
ALPHATEC SPINE, INC.
CI-11315-100
In Commercial Distribution

  • 00840180524411 ()


  • Bone awl, reusable
Stopped Awl
ALPHATEC SPINE, INC.
CI-11461
In Commercial Distribution

  • 00840180524022 ()


  • Bone awl, reusable
ALIF Variable Drill Guide, Lateral
ALPHATEC SPINE, INC.
CI-11415-02-02
In Commercial Distribution

  • 00840180522004 ()


  • Bone awl, reusable
ALIF Variable Drill Guide, Medial
ALPHATEC SPINE, INC.
CI-11415-02-01
In Commercial Distribution

  • 00840180521991 ()


  • Bone awl, reusable
ALIF Variable Drill
ALPHATEC SPINE, INC.
CI-11415-01
In Commercial Distribution

  • 00840180521984 ()


  • Bone awl, reusable
Stopped Awl, Short, 1/4-Sq, 30mm
ALPHATEC SPINE, INC.
CI-11406-30
In Commercial Distribution

  • 00840180521748 ()


  • Bone awl, reusable
Stopped Awl
ALPHATEC SPINE, INC.
CI-11359
In Commercial Distribution

  • 00840180519882 ()


  • Bone awl, reusable
Shoulder penetrating awl, 9 1/4'', curved, phenolic handle
AMBLER SURGICAL CORP.
Shoulder penetrating awl
In Commercial Distribution

  • 00190660106171 ()
43-547

  • Bone awl, reusable
Shoulder penetrating awl, 7 1/4'', curved, phenolic handle
AMBLER SURGICAL CORP.
Shoulder penetrating awl
In Commercial Distribution

  • 00190660106164 ()
43-545

  • Bone awl, reusable
Perthes bone awl, 8 1/4'', straight
AMBLER SURGICAL CORP.
Perthes bone awl
In Commercial Distribution

  • 00190660106119 ()
43-530

  • Bone awl, reusable
Obwegeser mandibular awl, 5 1/2'', slightly curved
AMBLER SURGICAL CORP.
Obwegeser mandibular awl
In Commercial Distribution

  • 00190660106089 ()
43-450

  • Bone awl, reusable
Kuntscher tibia awl, 11'', curved, 8.0mm diameter, diamond pointed
AMBLER SURGICAL CORP.
Kuntscher tibia awl
In Commercial Distribution

  • 00190660106072 ()
43-542

  • Bone awl, reusable
Kuntscher femur awl, 11'', curved, 10.0mm diameter, diamond pointed
AMBLER SURGICAL CORP.
Kuntscher femur awl
In Commercial Distribution

  • 00190660106065 ()
43-540

  • Bone awl, reusable
Bone awl, 5 3/4'', straight, with grooves
AMBLER SURGICAL CORP.
Bone awl
In Commercial Distribution

  • 00190660106058 ()
43-522

  • Bone awl, reusable
Bone awl, 5 3/4'', straight, square taper
AMBLER SURGICAL CORP.
Bone awl
In Commercial Distribution

  • 00190660106041 ()
43-524

  • Bone awl, reusable
Bone awl, 5 1/2'', straight, t-handle
AMBLER SURGICAL CORP.
Bone awl
In Commercial Distribution

  • 00190660106034 ()
43-520

  • Bone awl, reusable
5.5mm AWL TAP, CANNULATED - TROCAR
ALPHATEC SPINE, INC.
CI-11315-055-10
In Commercial Distribution

  • 00840180518304 ()


  • Bone awl, reusable
4.5mm AWL TAP, CANNULATED - TROCAR
ALPHATEC SPINE, INC.
CI-11315-045-10
In Commercial Distribution

  • 00840180518281 ()


  • Bone awl, reusable
ALIF Variable Awl Guide, Lateral
ALPHATEC SPINE, INC.
CI-10992-02-02
In Commercial Distribution

  • 00840180510230 ()


  • Bone awl, reusable
ALIF Variable Awl Guide, Medial
ALPHATEC SPINE, INC.
CI-10992-02-01
In Commercial Distribution

  • 00840180510223 ()


  • Bone awl, reusable
Angled Awl with Center Hole Stop
ALPHATEC SPINE, INC.
CI-10964-550
In Commercial Distribution

  • 00840180509555 ()


  • Bone awl, reusable
45° AMP Awl
ALPHATEC SPINE, INC.
CI-10959-165
In Commercial Distribution

  • 00840180508398 ()


  • Bone awl, reusable
No Description
SPINEGUARD
STARTER Pin 5
In Commercial Distribution

  • 03662674000389 ()

  • Outer Diameter: 1.6 Millimeter
  • Length: 389.5 Millimeter
D1PU0005

  • Bone awl, reusable
No Description
SPINEGUARD
STARTER Pin 1
In Commercial Distribution

  • 03662674000372 ()

  • Length: 308 Millimeter
  • Outer Diameter: 1.6 Millimeter
D1SP0001

  • Bone awl, reusable
No Description
SPINEGUARD
DSG Pin 5
In Commercial Distribution

  • 03662674000198 ()

  • Length: 373 Millimeter
  • Outer Diameter: 1.65 Millimeter
D1PU0005

  • Bone awl, reusable
No Description
SPINEGUARD
DSG Pin 1
In Commercial Distribution

  • 03662674000174 ()

  • Length: 292 Millimeter
  • Outer Diameter: 1.65 Millimeter
D1PU0001

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATES PEDIGUARD CANNULA 120mm
In Commercial Distribution

  • 03662674000167 ()

  • Length: 120 Millimeter
P2CN1110

  • Bone awl, reusable
No Description
SPINEGUARD
CANNULATED PEDIGUARD STARTER STYLET - TROCAR 120mm
In Commercial Distribution

  • 03662674000143 ()

  • Length: 120 Millimeter
P2ST1160

  • Bone awl, reusable
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