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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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Absolute Dentin™ - M595S3060

10ml. Blue Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S306
Not in Commercial Distribution

  • M595S3061 ()
  • M595S3060 ()
S306

  • Dental composite resin

Absolute Dentin™ - M595S3050

10ml. Tooth Shade Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S305
Not in Commercial Distribution

  • M595S3051 ()
  • M595S3050 ()
S305

  • Dental composite resin

Absolute Dentin™ - M595S3040

10ml. Artic White Absolute Dentin™ (2 Cartridges; 20ml. Total)
PARKELL, INC.
S304
Not in Commercial Distribution

  • M595S3041 ()
  • M595S3040 ()
S304

  • Dental composite resin

Integra™ - M595D6810

Replacement Reservoir Bottles for Integra™ Scaler (2 Bottles & Caps)
PARKELL, INC.
D681
Not in Commercial Distribution

  • M595D6811 ()
  • M595D6810 ()
D681

  • Ultrasonic dental scaling/debridement system

NA - M595D619GC0

Universal Ground Clip (Pkg. of 2 pcs.)
PARKELL, INC.
D619GC
Not in Commercial Distribution

  • M595D619GC1 ()
  • M595D619GC0 ()
D619GC

  • Endodontic apex locator

PerioSonic® - M595D5810

Empty Bottles for PerioSonic Irrigator D583 & D584 (6 Bottles & Caps)
PARKELL, INC.
D581
Not in Commercial Distribution

  • M595D5811 ()
  • M595D5810 ()
D581

  • Ultrasonic dental scaling/debridement system

Aurora™ - M595D5480

Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)
PARKELL, INC.
D548
Not in Commercial Distribution

  • M595D5481 ()
  • M595D5480 ()
D548

  • Dental/surgical polymerization lamp

Aurora™ - M595D5470

Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.)
PARKELL, INC.
D547
Not in Commercial Distribution

  • M595D5471 ()
  • M595D5470 ()
D547

  • Dental/surgical polymerization lamp

Aurora™ - M595D5430

Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.)
PARKELL, INC.
D543
Not in Commercial Distribution

  • M595D5431 ()
  • M595D5430 ()
D543

  • Dental/surgical polymerization lamp

Aurora™ - M595D5410

Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.)
PARKELL, INC.
D541
Not in Commercial Distribution

  • M595D5411 ()
  • M595D5410 ()
D541

  • Dental/surgical polymerization lamp

Sunoptic Technologies - M678DLS0

LED Rover Disoposable Series
SUNOPTIC TECHNOLOGIES LLC
Rover Lightsource series
In Commercial Distribution

  • M678DLS10 ()
  • M678DLS0 ()


  • Hand-held examination/treatment light

Axiom® - M665515NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
515NS
In Commercial Distribution

  • M665515NS1 ()
  • M665515NS0 ()

  • Lumen/Inner Diameter: 0.5 Inch
  • Outer Diameter: 0.6875 Inch
  • Wall: 0.09375in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665514NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
514NS
In Commercial Distribution

  • M665514NS1 ()
  • M665514NS0 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.625 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665512NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
512NS
In Commercial Distribution

  • M665512NS0 ()
  • M665512NS1 ()

  • Lumen/Inner Diameter: 0.375 Inch
  • Outer Diameter: 0.5 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665508NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
508NS
In Commercial Distribution

  • M665508NS1 ()
  • M665508NS0 ()

  • Lumen/Inner Diameter: 0.25 Inch
  • Outer Diameter: 0.4375 Inch
  • Wall: 0.09375 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665506NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
506NS
In Commercial Distribution

  • M665506NS1 ()
  • M665506NS0 ()

  • Lumen/Inner Diameter: 0.1875 Inch
  • Outer Diameter: 0.375 Inch
  • Wall: 0.09375 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665505NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
505NS
In Commercial Distribution

  • M665505NS1 ()
  • M665505NS0 ()

  • Lumen/Inner Diameter: 0.1875 Inch
  • Outer Diameter: 0.3125 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665503NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
503NS
In Commercial Distribution

  • M665503NS1 ()
  • M665503NS0 ()

  • Lumen/Inner Diameter: 0.078 Inch
  • Outer Diameter: 0.125 Inch
  • Wall: 0.023 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665501NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
501NS
In Commercial Distribution

  • M665501NS1 ()
  • M665501NS0 ()

  • Lumen/Inner Diameter: 0.03 Inch
  • Outer Diameter: 0.065 Inch
  • Wall: 0.018 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

NeoZoline - M633S38159022

Vent Tube Donaldson 1.10mm Silicone Pair
JEDMED INSTRUMENT COMPANY
S381590 2
In Commercial Distribution

  • M63338159023 ()
  • M633S38159022 ()

  • Lumen/Inner Diameter: 1.10 Millimeter
S381590 2

  • Tympanostomy tube

NeoZoline - M633S3815900

Vent Tube Donaldson 1.10mm Silicone Each
JEDMED INSTRUMENT COMPANY
S381590
In Commercial Distribution

  • M633S3815900 ()
  • M6333815901 ()

  • Lumen/Inner Diameter: 1.10 Millimeter
S381590

  • Tympanostomy tube

NeoZoline - M633S38158422

T-Tube 12mm Silicone Pair
JEDMED INSTRUMENT COMPANY
S381584 2
In Commercial Distribution

  • M63338158423 ()
  • M633S38158422 ()

  • Length: 12 Millimeter
S381584 2

  • Tympanostomy tube

NeoZoline - M633S38158222

T-Tube 9mm Silicone Pair
JEDMED INSTRUMENT COMPANY
S381582 2
In Commercial Distribution

  • M63338158223 ()
  • M633S38158222 ()

  • Length: 9 Millimeter
S381582 2

  • Tympanostomy tube

NeoZoline - M633S38158022

T-Tube 6mm Silicone Pair
JEDMED INSTRUMENT COMPANY
S381580 2
In Commercial Distribution

  • M633S38158022 ()
  • M633381580223 ()

  • Length: 6 Millimeter
S381580 2

  • Tympanostomy tube

NeoZoline - M633S38157622

Vent Tube Shah Tab 1.14mm Pair
JEDMED INSTRUMENT COMPANY
S381576 2
In Commercial Distribution

  • M63338157623 ()
  • M633S38157622 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381576 2

  • Tympanostomy tube

NeoZoline - M633S3815760

Vent Tube Shah Tab 1.14mm Each
JEDMED INSTRUMENT COMPANY
S381576
In Commercial Distribution

  • M6333815761 ()
  • M633S3815760 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381576

  • Tympanostomy tube

NeoZoline - M633S38157422

Vent Tube Mini Shah Tab 0.76mm Pair
JEDMED INSTRUMENT COMPANY
S381574 2
In Commercial Distribution

  • M63338157423 ()
  • M633S38157422 ()

  • Lumen/Inner Diameter: 0.76 Millimeter
S381574 2

  • Tympanostomy tube

NeoZoline - M633S3815740

Vent Tube Mini Shah Tab 0.76mm Each
JEDMED INSTRUMENT COMPANY
S381574
In Commercial Distribution

  • M6333815741 ()
  • M633S3815740 ()

  • Lumen/Inner Diameter: 0.76 Millimeter
S381574

  • Tympanostomy tube

NeoZoline - M633S38157222

Vent Tube Shah 1.14mm Pair
JEDMED INSTRUMENT COMPANY
S381572 2
In Commercial Distribution

  • M63338157223 ()
  • M633S38157222 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381572 2

  • Tympanostomy tube

NeoZoline - M633S3815720

Vent Tube Shah 1.14mm Each
JEDMED INSTRUMENT COMPANY
S381572
In Commercial Distribution

  • M6333815721 ()
  • M633S3815720 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381572

  • Tympanostomy tube
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