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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Polyaxial hemispherical screw Ø 4.5 Lg 35 mm
SCIENT'X
12VDP45-35
Not in Commercial Distribution

  • 03661380009129 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Monoaxial hemispherical screw Ø 8.0 Lg 35 mm
SCIENT'X
12VDHS80-35
Not in Commercial Distribution

  • 03661380009051 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Monoaxial hemispherical screw Ø 7.0 Lg 35 mm
SCIENT'X
12VDHS70-35
Not in Commercial Distribution

  • 03661380008979 ()

  • Outer Diameter: 7 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Monoaxial hemispherical screw Ø 6.2 Lg 35 mm
SCIENT'X
12VDHL62-35
Not in Commercial Distribution

  • 03661380008832 ()

  • Outer Diameter: 6.2 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Monoaxial hemispherical screw Ø 5.5 Lg 35 mm
SCIENT'X
12VDHD55-35
Not in Commercial Distribution

  • 03661380008795 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, sterile
Monoaxial hemispherical screw Ø 4.5 Lg 35 mm
SCIENT'X
12VDHD45-35
Not in Commercial Distribution

  • 03661380008771 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 35 Millimeter


  • Bone-screw internal spinal fixation system, sterile
LTX Bone Screw, Ø5.5 mm x 35 mm
ALPHATEC SPINE, INC.
259-5535
In Commercial Distribution

  • 00190376474137 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Metallic spinal interbody fusion cage
LTX Bone Screw, Ø5.0 mm x 35 mm
ALPHATEC SPINE, INC.
259-5035
In Commercial Distribution

  • 00190376474052 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5 Millimeter


  • Metallic spinal interbody fusion cage
MIS PEDICLE SCREW Ø8.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36208535
Not in Commercial Distribution

  • 03613720285502 ()
B36208535

  • Bone-screw internal spinal fixation system, non-sterile
MIS PEDICLE SCREW Ø7.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36207535
Not in Commercial Distribution

  • 03613720285441 ()
B36207535

  • Bone-screw internal spinal fixation system, non-sterile
MIS PEDICLE SCREW Ø6.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36206535
Not in Commercial Distribution

  • 03613720285380 ()
B36206535

  • Bone-screw internal spinal fixation system, non-sterile
MIS PEDICLE SCREW Ø5.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36205535
Not in Commercial Distribution

  • 03613720285328 ()
B36205535

  • Bone-screw internal spinal fixation system, non-sterile
MIS PEDICLE SCREW Ø4.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36204535
Not in Commercial Distribution

  • 03613720285281 ()
B36204535

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL PEDICLE SCREW Ø7.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36307535
Not in Commercial Distribution

  • 03613720285205 ()
B36307535

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL PEDICLE SCREW Ø6.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36306535
Not in Commercial Distribution

  • 03613720285151 ()
B36306535

  • Bone-screw internal spinal fixation system, non-sterile
MONOAXIAL PEDICLE SCREW Ø5.5 mm x 35 mm
MEDICREA INTERNATIONAL
B36305535
Not in Commercial Distribution

  • 03613720285106 ()
B36305535

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED REDUCTION SCREW Ø8.5 mm X 35 mm
MEDICREA INTERNATIONAL
B36118535
Not in Commercial Distribution

  • 03613720285038 ()
B36118535

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED REDUCTION SCREW Ø7.5 mm X 35 mm
MEDICREA INTERNATIONAL
B36117535
Not in Commercial Distribution

  • 03613720284963 ()
B36117535

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED REDUCTION SCREW Ø6.5 mm X 35 mm
MEDICREA INTERNATIONAL
B36116535
Not in Commercial Distribution

  • 03613720284901 ()
B36116535

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED REDUCTION SCREW Ø5.5 mm X 35 mm
MEDICREA INTERNATIONAL
B36115535
Not in Commercial Distribution

  • 03613720284840 ()
B36115535

  • Bone-screw internal spinal fixation system, non-sterile
CANNULATED REDUCTION SCREW Ø4.5 mm X 35 mm
MEDICREA INTERNATIONAL
B36114535
Not in Commercial Distribution

  • 03613720284789 ()
B36114535

  • Bone-screw internal spinal fixation system, non-sterile
Lateral Core Graft Bolt, 6.0 x 35 mm
ALPHATEC SPINE, INC.
612-60-35-C
In Commercial Distribution

  • 00190376525853 ()


  • Spinal bone screw, non-bioabsorbable
Lateral Core Graft Bolt, 5.5 x 35 mm
ALPHATEC SPINE, INC.
612-55-35-C
In Commercial Distribution

  • 00190376525761 ()


  • Spinal bone screw, non-bioabsorbable
ST 8.5 mm X 35 mm MULTI-AXIAL SCREW
SPINEVISION
U1-M835
In Commercial Distribution

  • 03663136022918 ()

  • Diameter: 8.5 Milliimeters Length: 35 Milliimeters


  • Spinal bone screw, non-bioabsorbable
Poly-axial Pedicle Screw, Ø7.5 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1012-7535
In Commercial Distribution

  • 00840185300867 ()
1012-7535

  • Bone-screw internal spinal fixation system, non-sterile
Poly-axial Pedicle Screw, Ø7.0 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1012-7035
In Commercial Distribution

  • 00840185300706 ()
1012-7035

  • Bone-screw internal spinal fixation system, non-sterile
PRATT Uterine Dilator, 10.9mm/11.6mm, size 33/35
BR Surgical, LLC
BR70-43833
In Commercial Distribution

  • 00840183527198 ()
BR70-43833

  • Fixed-diameter cervical dilator, reusable
Poly-axial Pedicle Screw, Ø6.5 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1012-6535
In Commercial Distribution

  • 00840185300546 ()
1012-6535

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø7.5 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1019-7535
In Commercial Distribution

  • 00840185302472 ()
1019-7535

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø7.0 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1019-7035
In Commercial Distribution

  • 00840185302373 ()
1019-7035

  • Bone-screw internal spinal fixation system, non-sterile
Mono-axial Pedicle Screw, Ø6.5 mm , 35 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
AISP-1019-6535
In Commercial Distribution

  • 00840185302274 ()
1019-6535

  • Bone-screw internal spinal fixation system, non-sterile
TI 8.5 mm X 35 mm MULTI-AXIAL SCREW
SPINEVISION
U1-M835T
In Commercial Distribution

  • 03663136015972 ()

  • Diameter: 8.5 Milliimeters Length: 35 Milliimeters


  • Spinal bone screw, non-bioabsorbable
Lateral Bone Screw, 6.0 x 35 mm x2
ALPHATEC SPINE, INC.
612-60-35-2-S
In Commercial Distribution

  • 00190376601410 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
Lateral Bone Screw, 5.5 x 35 mm x2
ALPHATEC SPINE, INC.
612-55-35-2-S
In Commercial Distribution

  • 00190376601328 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Fifth Ventricle Spiral-Port Ventricular Catheter, length 35 cm
SOPHYSA
FVPC2
In Commercial Distribution

  • 03760124135985 ()


  • Intracerebral infusion/drainage catheter, short-term
Mand. 1. Molar bands Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2893N9935
In Commercial Distribution

  • EFOR2893N99351 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2893N9935-050
In Commercial Distribution

  • EFOR2893N99350501 ()
  • EFOR2893N993505000 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2893N9935-010
In Commercial Distribution

  • EFOR2893N99350101 ()
  • EFOR2893N993501000 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2893N9935-005
In Commercial Distribution

  • EFOR2893N99350051 ()
  • EFOR2893N993500500 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2892N9935
In Commercial Distribution

  • EFOR2892N99351 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2892N9935-050
In Commercial Distribution

  • EFOR2892N99350501 ()
  • EFOR2892N993505000 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2892N9935-010
In Commercial Distribution

  • EFOR2892N99350101 ()
  • EFOR2892N993501000 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2883N9935-050
In Commercial Distribution

  • EFOR2883N99350501 ()
  • EFOR2883N993505000 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2883N9935-005
In Commercial Distribution

  • EFOR2883N99350051 ()
  • EFOR2883N993500500 ()


  • Orthodontic metal band
Mand. 1. Molar bands Dura-Fit left 35 welded
Forestadent Bernhard Förster GmbH
2892N9935-005
In Commercial Distribution

  • EFOR2892N99350051 ()
  • EFOR2892N993500500 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2883N9935
In Commercial Distribution

  • EFOR2883N99351 ()


  • Orthodontic metal band
Max. 1. Molar band Dura-Fit right 35 welded
Forestadent Bernhard Förster GmbH
2883N9935-010
In Commercial Distribution

  • EFOR2883N99350101 ()
  • EFOR2883N993501000 ()


  • Orthodontic metal band
BioQuick-Brackets Roth .022" 200 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
-706-0998
In Commercial Distribution

  • EFOR70609981 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 100 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
-706-0997
In Commercial Distribution

  • EFOR70609971 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 20 Brackets 3-5 w. hook
Forestadent Bernhard Förster GmbH
-706-0996
In Commercial Distribution

  • EFOR70609961 ()


  • Orthodontic bracket, metal
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