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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LOW PROFILE BURR HOLE COVER, W/TAB, 20mm
Stryker Leibinger GmbH & Co. KG
53-05520
In Commercial Distribution

  • 04546540394071 ()

  • Thickness: 0.5 Millimeter
53-05520

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE BURR HOLE COVER, W/TAB, 14mm
Stryker Leibinger GmbH & Co. KG
53-05514
In Commercial Distribution

  • 04546540394064 ()

  • Thickness: 0.5 Millimeter
53-05514

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE BURR HOLE COVER, W/TAB, 10mm
Stryker Leibinger GmbH & Co. KG
53-05510
In Commercial Distribution

  • 04546540394057 ()

  • Thickness: 0.5 Millimeter
53-05510

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE BURR HOLE COVER, W/TAB, 7mm
Stryker Leibinger GmbH & Co. KG
53-05507
In Commercial Distribution

  • 04546540394040 ()

  • Thickness: 0.5 Millimeter
53-05507

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE PLATE
Stryker Leibinger GmbH & Co. KG
53-05406
In Commercial Distribution

  • 04546540394033 ()

  • Number of Screw Holes: 4.0 Holes
53-05406

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE 3-D BOX PLATE
Stryker Leibinger GmbH & Co. KG
53-05228
In Commercial Distribution

  • 04546540394026 ()

  • 3D Plates: 2x2 Holes
53-05228

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE PLATE
Stryker Leibinger GmbH & Co. KG
53-05216
In Commercial Distribution

  • 04546540394019 ()

  • Number of Screw Holes: 2.0 Holes
53-05216

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE PLATE, WITH TAB
Stryker Leibinger GmbH & Co. KG
53-05212
In Commercial Distribution

  • 04546540394002 ()

  • Number of Screw Holes: 2.0 Holes
53-05212

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE PLATE, STRAIGHT
Stryker Leibinger GmbH & Co. KG
53-05164
In Commercial Distribution

  • 04546540393999 ()

  • Number of Screw Holes: 16.0 Holes
53-05164

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OSTEOTOMY PLATE, LOCKING
Stryker Leibinger GmbH & Co. KG
55-10580
In Commercial Distribution

  • 04546540399991 ()

  • Length: 46.0 Millimeter
  • Number of Screw Holes: 8.0 Holes
55-10580

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LE FORT I PLATE, 6MM ADVANCEMENT, RIGHT
Stryker Leibinger GmbH & Co. KG
55-12706
In Commercial Distribution

  • 04546540394347 ()

  • Number of Screw Holes: 11.0 Holes
  • Bar Length: 6.0 Millimeter
55-12706

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
SCREWDRIVER BLADE, 1.5/1.7MM EMERG.
Stryker Leibinger GmbH & Co. KG
62-15000
In Commercial Distribution

  • 04546540394163 ()

  • Length: 72.0 Millimeter
62-15000

  • Surgical screwdriver, reusable
Plate, rigid
Stryker Leibinger GmbH & Co. KG
53-06212
In Commercial Distribution

  • 04546540394125 ()

  • Number of Screw Holes: 2.0 Holes
53-06212

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Low Profile Plate, straight
Stryker Leibinger GmbH & Co. KG
53-05804
In Commercial Distribution

  • 04546540394118 ()

  • Number of Screw Holes: 8.0 Holes
53-05804

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE GAP PLATE, LARGE
Stryker Leibinger GmbH & Co. KG
53-05622
In Commercial Distribution

  • 04546540394101 ()

  • Number of Screw Holes: 6.0 Holes
53-05622

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE GAP PLATE, SMALL
Stryker Leibinger GmbH & Co. KG
53-05612
In Commercial Distribution

  • 04546540394095 ()

  • Number of Screw Holes: 6.0 Holes
53-05612

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
LOW PROFILE DOUBLE-Y-PLATE, WITH BAR
Stryker Leibinger GmbH & Co. KG
53-05608
In Commercial Distribution

  • 04546540394088 ()

  • Bar Length: 4.0 Millimeter
  • Number of Screw Holes: 6.0 Holes
53-05608

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Screw Driver, WS 5mm, Cannulated
I.T.S. GmbH
56502
In Commercial Distribution

  • 09120034306167 ()
56502

  • Surgical screwdriver, reusable
Screwdriver, Handle 25mm, WS 2.5, L=120mm. Can. 1.7mm
I.T.S. GmbH
56253-120
In Commercial Distribution

  • 09120034305894 ()
56253-120

  • Surgical screwdriver, reusable
AO Screw Adaptor, Socket Wrench
I.T.S. GmbH
53400
In Commercial Distribution

  • 09120034303791 ()
53400

  • Surgical torque wrench adaptor
Large Hexagonal Screwdriver, 3.5mm, Quick Coupling End
I.T.S. GmbH
KM 47-954
In Commercial Distribution

  • 09120034307393 ()
KM 47-954

  • Surgical screwdriver, reusable
Screw Driver, WS 2.5, Self Holding Sleeve
I.T.S. GmbH
56252
In Commercial Distribution

  • 09120034303784 ()
56252

  • Surgical screwdriver, reusable
Screw Driver, Torque, T9x70
I.T.S. GmbH
56095-70
In Commercial Distribution

  • 09120034300684 ()
56095-70

  • Surgical screwdriver, reusable
Screw Driver, Handle 25mm, WS 2.5, L=170mm, Can. 1.7mm
I.T.S. GmbH
56253-170
In Commercial Distribution

  • 09120034300646 ()
56253-170

  • Surgical screwdriver, reusable
Screw Driver, WS 3.5, Conic, Self Holding
I.T.S. GmbH
56352-SH
In Commercial Distribution

  • 09120034300639 ()
56352-SH

  • Surgical screwdriver, reusable
Screwdriver, Tapered, T20 TiN
OMNIA MEDICAL, LLC
17-5A-DRV5
In Commercial Distribution

  • 00843511113100 ()


  • Surgical screwdriver, reusable
Screwdriver, Straight, T15
OMNIA MEDICAL, LLC
17-5A-DRV4
In Commercial Distribution

  • 00843511113094 ()


  • Surgical screwdriver, reusable
Screwdriver, Flex, Tapered, T20
OMNIA MEDICAL, LLC
17-5A-DRV3
In Commercial Distribution

  • 00843511113087 ()


  • Surgical screwdriver, reusable
Screwdriver, Tapered, T20
OMNIA MEDICAL, LLC
17-5A-DRV2
In Commercial Distribution

  • 00843511113070 ()


  • Surgical screwdriver, reusable
Screwdriver, Straight, T20
OMNIA MEDICAL, LLC
17-5A-DRV1
In Commercial Distribution

  • 00843511113063 ()


  • Surgical screwdriver, reusable
PsiF Mallet with Joint Finder Feature
OMNIA MEDICAL, LLC
22-5P-MAL4
In Commercial Distribution

  • 00843511112943 ()


  • Surgical mallet
SCREW COVER INSERTER
OMNIA MEDICAL, LLC
10-5C-DRV2
In Commercial Distribution

  • 00843511105235 ()
10-5C-DRV2

  • Surgical screwdriver, reusable
ANGLED CERVICAL DRIVER
OMNIA MEDICAL, LLC
10-5C-DRV1
In Commercial Distribution

  • 00843511105228 ()
10-5C-DRV1

  • Surgical screwdriver, reusable
Insertion / Removal Instrumentation, Hallux Osteotomy Plate
I.T.S. GmbH
62702
In Commercial Distribution

  • 09120047301944 ()
62702

  • Surgical mallet
Screwdriver, WS 2.5, Conical Head
I.T.S. GmbH
56252-150
In Commercial Distribution

  • 09120047298374 ()
56252-150

  • Surgical screwdriver, reusable
Threaded Bar
I.T.S. GmbH
62700-1
In Commercial Distribution

  • 09120047297285 ()
62700-1

  • Surgical mallet
MALLET
B-ONE ORTHO, CORP.
8819022000
In Commercial Distribution

  • 00843575102690 ()
8819022000

  • Surgical mallet
Golden Spike Driver, not threaded
OMNIA MEDICAL, LLC
21-5L-INS7
In Commercial Distribution

  • 00843511128173 ()
21-5L-INS7

  • Orthopaedic inorganic implant inserter/extractor, reusable
PsiF Mallet with Joint Finder Feature
OMNIA MEDICAL, LLC
22-5P-MAL3
In Commercial Distribution

  • 00843511128166 ()


  • Surgical mallet
PsiF Mallet with Joint Finder Feature
OMNIA MEDICAL, LLC
22-5P-MAL2
In Commercial Distribution

  • 00843511128159 ()


  • Surgical mallet
PsiF Mallet
OMNIA MEDICAL, LLC
22-5P-MAL1
In Commercial Distribution

  • 00843511128135 ()


  • Surgical mallet
Cervical Screw Removal Tool
OMNIA MEDICAL, LLC
10-5C-RMV1
In Commercial Distribution

  • 00843511123567 ()
10-5C-RMV1

  • Surgical screwdriver, reusable
3.0 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD30
In Commercial Distribution

  • 00843511123222 ()


  • Surgical screwdriver, reusable
Drill Bit
OMNIA MEDICAL, LLC
99-5U-STDB
In Commercial Distribution

  • 00843511122829 ()


  • Surgical screwdriver, reusable
4.0 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD40
In Commercial Distribution

  • 00843511122713 ()


  • Surgical screwdriver, reusable
2.5 mm HEX DRIVER
OMNIA MEDICAL, LLC
99-5P-HD25
In Commercial Distribution

  • 00843511122690 ()


  • Surgical screwdriver, reusable
Universal Slap Hammer
OMNIA MEDICAL, LLC
99-5A-SLP1
In Commercial Distribution

  • 00843511122157 ()


  • Surgical mallet
60 Degree Flex Tube Driver
OMNIA MEDICAL, LLC
17-5A-DV60
In Commercial Distribution

  • 00843511122065 ()


  • Surgical screwdriver, reusable
45 Degree Flex Tube Driver
OMNIA MEDICAL, LLC
17-5A-DV45
In Commercial Distribution

  • 00843511122058 ()


  • Surgical screwdriver, reusable
30 Degree Flex Tube Driver
OMNIA MEDICAL, LLC
17-5A-DV30
In Commercial Distribution

  • 00843511122041 ()


  • Surgical screwdriver, reusable
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