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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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CERTEX 3.5 X 18mm THREADED X 11mm SMOOTH X 29mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0254
Not in Commercial Distribution

  • M697X06702541 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 29 Millimeter
  • Length: 18 Millimeter
  • Length: 11 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.5 X 16mm THREADED X 11mm SMOOTH X 27mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0281
Not in Commercial Distribution

  • M697X06702811 ()

  • Length: 27 Millimeter
  • Length: 11 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Length: 16 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 16mm THREADED X 11mm SMOOTH X 27mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0251
Not in Commercial Distribution

  • M697X06702511 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 11 Millimeter
  • Length: 27 Millimeter
  • Length: 16 Millimeter


  • Spinal bone screw, non-bioabsorbable
Size: 10. Contains one each of 331001 & 341010.
Boston Medical Products, Inc.
331000
In Commercial Distribution

  • EBES3310001 ()

  • Outer Diameter (Cannula): 13 mm
  • Size: 10
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 11 mm
331000

  • Tracheostoma button
  • Tracheotome
Size: 6. Contains one each of 330601 & 341006.
Boston Medical Products, Inc.
330600
In Commercial Distribution

  • EBES3306001 ()

  • Outer Diameter (Cannula): 11 mm
  • Size: 6
  • Length (Cannula): 101 mm
  • Outer Diameter (Fenestrator): 8 mm
330600

  • Tracheostoma button
  • Tracheotome
Pratt Uterine Dilator, Double-Ended
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH30-560-3335
In Commercial Distribution

  • H834MH3056033350 ()
  • 10381780451426 ()

  • Outer Diameter: 11 Millimeter
  • Catheter Gauge: 35 French
  • Outer Diameter: 11.5 Millimeter
  • Catheter Gauge: 33 French
  • 11-1/2"
MH30-560-3335

  • Fixed-diameter cervical dilator, reusable
Pratt Uterine Dilator, Double-Ended
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
30-560-3335
In Commercial Distribution

  • H8343056033350 ()
  • 10381780449164 ()

  • Outer Diameter: 11 Millimeter
  • Outer Diameter: 11.5 Millimeter
  • 11-1/2"
  • Catheter Gauge: 33 French
  • Catheter Gauge: 35 French
30-560-3335

  • Fixed-diameter cervical dilator, reusable
The Introducer Kit facilitates percutaneous entry of an intravascular device. Model 8983 contains 7F, 11cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire.
Vascular Solutions, Inc.
8984
In Commercial Distribution

  • M20689841 ()

  • Introducer Sheath Compatibility: 7 French
  • Length: 11 Centimeter
  • Needle Gauge: 20 Gauge
  • Guidewire Length: 40 Centimeter


  • Vascular catheter introduction set, nonimplantable
zenith sims vaginal retractor, double-ended, flat handle, size 2, blades 1" x 3" deep (2.5 cm x 7.6 cm) & 1-1/4" x 3-1/4" deep (3.2 cm x 8.3 cm), 6-1/4" (16.0 cm)
NOVO SURGICAL, INC.
OB96331-13
In Commercial Distribution

  • G586OB96331130 ()
OB96331-13

  • Self-retaining surgical retractor, reusable
zenith sims vaginal retractor, double-ended, flat handle, size 1, blades 1" x 2-1/2" deep (2.5 cm x 6.4 cm) & 1-1/4" x 3" deep (3.2 cm x 7.6 cm), 5-1/8" (13.0 cm)
NOVO SURGICAL, INC.
OB96331-12
In Commercial Distribution

  • G586OB96331120 ()
OB96331-12

  • Self-retaining surgical retractor, reusable
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