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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A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4240-4226
In Commercial Distribution

  • 09421028119795 ()
4240-4226

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 21 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0169
In Commercial Distribution

  • 10840642108835 ()
11-0169

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 19 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0168
In Commercial Distribution

  • 10840642108828 ()
11-0168

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 17 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0167
In Commercial Distribution

  • 10840642108811 ()
11-0167

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 15 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0166
In Commercial Distribution

  • 10840642108804 ()
11-0166

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 13 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0165
In Commercial Distribution

  • 10840642108798 ()
11-0165

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 11 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0164
In Commercial Distribution

  • 10840642108781 ()
11-0164

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 9 mm (H), 8° Lordotic
Spine Wave, Inc.
11-0163
In Commercial Distribution

  • 10840642108774 ()
11-0163

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 21 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0069
In Commercial Distribution

  • 10840642108705 ()
11-0069

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 19 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0068
In Commercial Distribution

  • 10840642108699 ()
11-0068

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 17 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0067
In Commercial Distribution

  • 10840642108682 ()
11-0067

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 15 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0066
In Commercial Distribution

  • 10840642108675 ()
11-0066

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 13 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0065
In Commercial Distribution

  • 10840642108668 ()
11-0065

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 11 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0064
In Commercial Distribution

  • 10840642108651 ()
11-0064

  • Metallic spinal interbody fusion cage
Modular Spacer, SSA, 26 mm (W) x 26 mm (L) x 9 mm (H), 15° Lordotic
Spine Wave, Inc.
11-0063
In Commercial Distribution

  • 10840642108644 ()
11-0063

  • Metallic spinal interbody fusion cage
Radiation Reducing Glove
EMERSON & CO SRL
RR165
In Commercial Distribution

  • 08054301890756 ()
  • 08054301890015 ()
RR165

  • Radiation shielding glove
Screw 4.5 x 35 mm (LAG), cannul.
Inion Oy
1
In Commercial Distribution

  • 06438408003677 ()
OSD-4535

  • Bioabsorbable orthopaedic bone screw
Screw 3.5 x 35 mm (LAG), cannul.
Inion Oy
1
In Commercial Distribution

  • 06438408003646 ()
OSD-3535

  • Bioabsorbable orthopaedic bone screw
Profit Gray Cushion Liner Size 35 6mm
Alps South, LLC
PFGFR35-6
In Commercial Distribution

  • 00713980035343 ()


  • External limb prosthesis socket liner
Profit Gray Cushion Liner Size 35 3mm
Alps South, LLC
PFGFR35-3
In Commercial Distribution

  • 00713980035336 ()


  • External limb prosthesis socket liner
Profit Gray Locking Liner Size 35 6mm
Alps South, LLC
PFGDT35-6
In Commercial Distribution

  • 00713980035329 ()


  • External limb prosthesis socket liner
Profit Gray Locking Liner Size 35 3mm
Alps South, LLC
PFGDT35-3
In Commercial Distribution

  • 00713980035312 ()


  • External limb prosthesis socket liner
Softsil Grey Silicone Cushion Liner Size 35
Alps South, LLC
SSGSC-35
In Commercial Distribution

  • 00713980032205 ()


  • External limb prosthesis socket liner
Softsil Grey Silicone Locking Liner Size 35
Alps South, LLC
SSGSL-35
In Commercial Distribution

  • 00713980032090 ()


  • External limb prosthesis socket liner
Custom 35 CM Silicone Pro Locking 3.0mm
Alps South, LLC
LSL3.0-35-C
In Commercial Distribution

  • 00713980012412 ()


  • External limb prosthesis socket liner
MULTI AXIAL PEDICLE SCREW 8.5 X 35
ELITE SURGICAL SUPPLIES (PTY) LTD
CZ8535CT
In Commercial Distribution

  • 06009708426192 ()
CZ8535CT

  • Spinal bone screw, non-bioabsorbable
  • Spinal bone set screw
  • Spinal bone screw head/rod adaptor
MULTI AXIAL PEDICLE SCREW 7.5 X 35
ELITE SURGICAL SUPPLIES (PTY) LTD
CZ7535CT
In Commercial Distribution

  • 06009708426147 ()
CZ7535CT

  • Spinal bone screw, non-bioabsorbable
  • Spinal bone set screw
  • Spinal bone screw head/rod adaptor
MULTI AXIAL PEDICLE SCREW 6.5 X 35
ELITE SURGICAL SUPPLIES (PTY) LTD
CZ6535CT
In Commercial Distribution

  • 06009708426086 ()
CZ6535CT

  • Spinal bone screw, non-bioabsorbable
  • Spinal bone set screw
  • Spinal bone screw head/rod adaptor
MULTI AXIAL PEDICLE SCREW 5.5 X 35
ELITE SURGICAL SUPPLIES (PTY) LTD
CZ5535CT
In Commercial Distribution

  • 06009708426031 ()
CZ5535CT

  • Spinal bone screw, non-bioabsorbable
  • Spinal bone set screw
  • Spinal bone screw head/rod adaptor
VivaSight 2 DLT Kit 35 Fr - LEFT
Ambu A/S
412351000
In Commercial Distribution

  • 05707480145713 ()
  • 05707480145706 ()

  • Lumen/Inner Diameter: 4.4 Millimeter
  • Outer Diameter: 10.5 Millimeter
  • Adult
412351000

  • Endobronchial tube
Polyaxial Reduction Screw 6.75 x 35 mm
Seaspine Orthopedics Corporation
11-6735
In Commercial Distribution

  • 10889981000608 ()

  • 6.75 x 35 mm
11-6735

  • Spinal bone screw, non-bioabsorbable
Polyaxial Reduction Screw 6.0 x 35 mm
Seaspine Orthopedics Corporation
11-6035
In Commercial Distribution

  • 10889981000530 ()

  • 6.0 x 35 mm
11-6035

  • Spinal bone screw, non-bioabsorbable
Pump NSC Soft 8FR 35/14 NS
REPRO MED SYSTEMS, INC.
P1N1S108N
In Commercial Distribution

  • 00659443002777 ()
P1N1S108N

  • Emergency airway clearance suction system, manual
REPL FSP S0FT 14FR 35/14 ST
REPRO MED SYSTEMS, INC.
R1F1S114S
In Commercial Distribution

  • 00659443002593 ()
R1F1S114S

  • Emergency airway clearance suction system, manual
REPL FSP SOFT 10FR 35/14 NS
REPRO MED SYSTEMS, INC.
R1F1S110N
In Commercial Distribution

  • 00659443002586 ()
R1F1S110N

  • Emergency airway clearance suction system, manual
REPL FSP 8/10FR 35/14 ST
REPRO MED SYSTEMS, INC.
R1F00181S
In Commercial Distribution

  • 00659443002340 ()
R1F00181S

  • Emergency airway clearance suction system, manual
PUMP 2FSP 8/10FR 35/14 ST
REPRO MED SYSTEMS, INC.
P2F00181S
In Commercial Distribution

  • 00659443002180 ()
P2F00181S

  • Emergency airway clearance suction system, manual
PUMP NSC SOFT 14FR 35/14 ST
REPRO MED SYSTEMS, INC.
P1N1S114S
In Commercial Distribution

  • 00659443002142 ()
P1N1S114S

  • Emergency airway clearance suction system, manual
PUMP NSC SOFT 14FR 35/14 NS
REPRO MED SYSTEMS, INC.
P1N1S114N
In Commercial Distribution

  • 00659443002135 ()
P1N1S114N

  • Emergency airway clearance suction system, manual
PUMP NSC SOFT 10FR 35/14 ST
REPRO MED SYSTEMS, INC.
P1N1S110S
In Commercial Distribution

  • 00659443002128 ()
P1N1S110S

  • Emergency airway clearance suction system, manual
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