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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GASKIN FRAGMENT FORCEPS WITH PLATFORM DELICATE SMOOTH ANGLED TIP
SONTEC INSTRUMENTS, INC.
14-5350
In Commercial Distribution

  • 00192896073906 ()

  • 11 Millimeter Tip
14-5350

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
TPLO GAUGE DOUBLE ENDED TIPS
SONTEC INSTRUMENTS, INC.
330-456
In Commercial Distribution

  • 00192896078024 ()

  • 11/12 Millimeter
330-456

  • Surgical gouge
ALM RETRACTOR
SONTEC INSTRUMENTS, INC.
230-382
In Commercial Distribution

  • 00192896077270 ()

  • 11 Millimeter Blade
  • Length: 2.75 Inch
230-382

  • Self-retaining surgical retractor, reusable
CASTROVIEJO NEEDLE HOLDER WITHOUT LOCK STRAIGHT TUNGSTEN CARBIDE DUST TIP FLAT HANDLE TITANIUM
SONTEC INSTRUMENTS, INC.
T15-1916
In Commercial Distribution

  • 00192896074538 ()

  • 11 Millimeter Tip
T15-1916

  • Suturing needle holder, reusable
CORNEAL TREPHINE BLADE
SONTEC INSTRUMENTS, INC.
12-1263
In Commercial Distribution

  • 00192896072466 ()

  • 11 Millimeter Blade
12-1263

  • Ophthalmic knife, reusable
HELVESTON TISSUE RETRACTOR SINGLE ENDED CURVED BLADE FLAT HANDLE
SONTEC INSTRUMENTS, INC.
10-5491
In Commercial Distribution

  • 00192896072343 ()

  • Length: 5 Inch
  • 11 Millimeter Blade
10-5491

  • Ophthalmic surgical probe, reusable
GRACEY CURETTE RIGID #3-4 SHORT CONTRA-ANGLE TERMINAL SHANK REACH LIGHT HANDLE
SONTEC INSTRUMENTS, INC.
1102-RESCG3R-4R
In Commercial Distribution

  • 00192896088030 ()

  • 11 Millimeter Shank
1102-RESCG3R-4R

  • Periodontal curette
INGE LAMINA SPREADER RETRACTOR CONCAVE SERRATED BLADES
SONTEC INSTRUMENTS, INC.
417-056
In Commercial Distribution

  • 00192896094710 ()

  • 11 Millimeter Tip
  • Length: 11 Inch
417-056

  • Surgical retractor/retraction system blade, reusable
CASTROVIEJO CORNEOSCLERAL SCISSORS MEDIUM RIGHT ANGLED BLADES FENESTRATED HANDLE
SONTEC INSTRUMENTS, INC.
13-1320F
In Commercial Distribution

  • 00192896099531 ()

  • Length: 4.25 Inch
  • 11 Millimeter Blades
13-1320F

  • Corneal scissors, reusable
CAPENER LAMINA GOUGE BAYONET TIP PHENOLIC HANDLE
SONTEC INSTRUMENTS, INC.
330-058
In Commercial Distribution

  • 00192896088443 ()

  • 11 Millimeter Tip
  • Length: 24 Centimeter
330-058

  • Surgical gouge
Kelman McPherson Tying Forceps Delicate Angle
SONTEC INSTRUMENTS, INC.
14-5280
In Commercial Distribution

  • 00192896102361 ()

  • Tip 11 Millimeters


  • Ophthalmic surgical device handling forceps, reusable
CASTROVIEJO CORNEOSCLERAL SCISSORS MEDIUM LEFT ANGLED BLADES FENESTRATED HANDLE
SONTEC INSTRUMENTS, INC.
13-1330F
In Commercial Distribution

  • 00192896014244 ()

  • Length: 4.25 Inch
  • 11 Millimeter Blades
13-1330F

  • Corneal scissors, reusable
DESMARRES LID RETRACTOR BLUE ELECTRO COAT
SONTEC INSTRUMENTS, INC.
10-4201
In Commercial Distribution

  • 00192896012271 ()

  • 11 Millimeter Blade
  • Length: 5.5 Inch
10-4201

  • Eyelid speculum, reusable
DESMARRES LID RETRACTOR
SONTEC INSTRUMENTS, INC.
10-4200
In Commercial Distribution

  • 00192896012264 ()

  • 11 Millimeter Blade
  • Length: 5.5 Inch
10-4200

  • Eyelid speculum, reusable
SHEEHAN OSTEOTOME
SONTEC INSTRUMENTS, INC.
330-891
In Commercial Distribution

  • 00192896031012 ()

  • Length: 6.25 Inch
  • 11 Millimeter Tip
330-891

  • Orthopaedic osteotome handle
TWO HANDED CURETTE STRAIGHT TEAR DROP TIP BLACK HANDLE
SONTEC INSTRUMENTS, INC.
320-589
In Commercial Distribution

  • 00192896028098 ()

  • Length: 18 Inch
  • 11 Millimeter Tip
320-589

  • Bone curette, reusable
TISSUE NIPPER
SONTEC INSTRUMENTS, INC.
199-223
In Commercial Distribution

  • 00192896024786 ()

  • Length: 4.5 Inch
  • 11 Millimeter Tip
199-223

  • Nail extraction forceps
FREEDOM SPLINT
E.M. ADAMS, INC.
EP26-0650M-1
In Commercial Distribution

  • 50840200307234 ()
  • 10840200307243 ()

  • 11" X 19"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP26-0421-1
In Commercial Distribution

  • 50840200306275 ()
  • 10840200306284 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP26-0281-1
In Commercial Distribution

  • 50840200306015 ()
  • 10840200306024 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0304U-1
In Commercial Distribution

  • 50840200314645 ()
  • 10840200314654 ()

  • 11" x 14"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0301U-1
In Commercial Distribution

  • 50840200314522 ()
  • 10840200314531 ()

  • 5" x 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0204U-1
In Commercial Distribution

  • 50840200314362 ()
  • 10840200314371 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0203U-1
In Commercial Distribution

  • 50840200314300 ()
  • 10840200314319 ()

  • 9" x 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0304B-1
In Commercial Distribution

  • 50840200308392 ()
  • 10840200308400 ()

  • 11" X 14"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0301G-1
In Commercial Distribution

  • 50840200308217 ()
  • 10840200308226 ()

  • 5" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0301B-1
In Commercial Distribution

  • 50840200308194 ()
  • 10840200308202 ()

  • 5" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0204G-1
In Commercial Distribution

  • 50840200308118 ()
  • 10840200308127 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0204B-1
In Commercial Distribution

  • 50840200308095 ()
  • 10840200308103 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0203G-1
In Commercial Distribution

  • 50840200308057 ()
  • 10840200308066 ()

  • 9" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0203B-1
In Commercial Distribution

  • 50840200308033 ()
  • 10840200308042 ()

  • 9" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0104U-1
In Commercial Distribution

  • 50840200307913 ()
  • 10840200307922 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0104G-1
In Commercial Distribution

  • 50840200307852 ()
  • 10840200307861 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0104B-1
In Commercial Distribution

  • 50840200307838 ()
  • 10840200307847 ()

  • 11" X 12"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0103U-1
In Commercial Distribution

  • 50840200307814 ()
  • 10840200307823 ()

  • 9" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0103G-1
In Commercial Distribution

  • 50840200307692 ()
  • 10840200307700 ()

  • 9" X 11"


  • Limb/torso/head restraint, reusable
ELBOW SPLINT
E.M. ADAMS, INC.
EP28-0103B-1
In Commercial Distribution

  • 50840200307678 ()
  • 10840200307687 ()

  • 9" X 11"


  • Limb/torso/head restraint, reusable
The AURAGEN™ Cortical Surface Electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical Electrodes are available with platinum contacts and vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M75
Not in Commercial Distribution

  • M27240M751 ()
  • 10381780035213 ()

  • 11 platinum contacts


  • Cortical electrode
SPACER BLOCK HANDLE 10MM / 11MM TRIATHLON PKR INSTRUMENTS
Howmedica Osteonics Corp.
5650-1011
In Commercial Distribution

  • 07613327249354 ()

  • Size: 10/11
5650-1011

  • Surgical instrument handle, non-torque-limiting
No Description
Biomet Orthopedics, LLC
110030308
In Commercial Distribution

  • 00887868134937 ()

  • 11 HOLE 197MM
110030308

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110030408
In Commercial Distribution

  • 00887868134883 ()

  • 11 HOLE 197MM
110030408

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110030208
In Commercial Distribution

  • 00887868134821 ()

  • 11 HOLE 190MM
110030208

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110030108
In Commercial Distribution

  • 00887868134777 ()

  • 11 HOLE 190MM
110030108

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
110030303
In Commercial Distribution

  • 00887868134722 ()

  • 11 HOLE 197MM
110030303

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
110030403
In Commercial Distribution

  • 00887868134678 ()

  • 11 HOLE 197MM
110030403

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
110030103
In Commercial Distribution

  • 00887868134623 ()

  • 11 HOLE 190MM
110030103

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Biomet Orthopedics, LLC
110030203
In Commercial Distribution

  • 00887868134579 ()

  • 11 HOLE 190MM
110030203

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
No Description
Zimmer, Inc.
2259-01-45
In Commercial Distribution

  • 00889024049048 ()

  • 11 mm Diameter
  • Length: 105 Millimeter
00-2259-001-45

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Zimmer, Inc.
2259-01-42
In Commercial Distribution

  • 00889024049031 ()

  • Length: 100 Millimeter
  • 11 mm Diameter
00-2259-001-42

  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
Zimmer, Inc.
2259-01-37
In Commercial Distribution

  • 00889024049017 ()

  • Length: 90 Millimeter
  • 11 mm Diameter
00-2259-001-37

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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