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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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NeoZoline - M633S3815140

Vent Tube Modified Armstrong 1.14mm Each
JEDMED INSTRUMENT COMPANY
S381514
In Commercial Distribution

  • M6333815141 ()
  • M633S3815140 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381514

  • Tympanostomy tube

NeoZoline - M633S3815120

Vent Tube Armstrong 1.14mm Tab Each
JEDMED INSTRUMENT COMPANY
S381512
In Commercial Distribution

  • M6333815121 ()
  • M633S3815120 ()

  • Lumen/Inner Diameter: 1.14 Millimeter
S381512

  • Tympanostomy tube

NeoZoline - M633S38150222

Vent Tube Collar Button 1.27mm Tab Pair
JEDMED INSTRUMENT COMPANY
S381502 2
In Commercial Distribution

  • M633S38150222 ()
  • M63338150223 ()

  • Lumen/Inner Diameter: 1.27 Millimeter
S381502 2

  • Tympanostomy tube

NeoZoline - M633S3815020

Vent Tube Collar Button 1.27mm Tab Each
JEDMED INSTRUMENT COMPANY
S381502
In Commercial Distribution

  • M6333815021 ()
  • M633S3815020 ()

  • Lumen/Inner Diameter: 1.27 Millimeter
S381502

  • Tympanostomy tube

NeoZoline - M633S3815000

Vent Tube Collar Button 1.27mm Each
JEDMED INSTRUMENT COMPANY
S381500
In Commercial Distribution

  • M633S3815000 ()
  • M6333815001 ()

  • Lumen/Inner Diameter: 1.27 Millimeter
S381500

  • Tympanostomy tube

Sunoptic Technologies - M678SLS0

LED Rover Disoposable, Non-Sterile Series
SUNOPTIC TECHNOLOGIES LLC
Rover Lightsource series
In Commercial Distribution

  • M678SLS10 ()
  • M678SLS0 ()


  • Hand-held examination/treatment light

Sunoptic Technologies - M678DLS0

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

  • M678DLS10 ()
  • M678DLS0 ()


  • Hand-held examination/treatment light

Axiom® - M665516NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
516NS
In Commercial Distribution

  • M665516NS0 ()
  • M665516NS1 ()

  • Lumen/Inner Diameter: 0.5 Inch
  • Outer Diameter: 0.75 Inch
  • Wall: 0.125 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

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® - M665510NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
510NS
In Commercial Distribution

  • M665510NS1 ()
  • M665510NS0 ()

  • Lumen/Inner Diameter: 0.3125 Inch
  • Outer Diameter: 0.4375 Inch
  • Wall: 0.0625 in.
  • Length: 50 Feet


  • Suction/irrigation tubing, single-use

Axiom® - M665509NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
509NS
In Commercial Distribution

  • M665509NS1 ()
  • M665509NS0 ()

  • Lumen/Inner Diameter: 0.25 Inch
  • Outer Diameter: 0.5 Inch
  • Wall: 0.125 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® - M665507NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
507NS
In Commercial Distribution

  • M665507NS1 ()
  • M665507NS0 ()

  • Lumen/Inner Diameter: 0.25 Inch
  • Outer Diameter: 0.375 Inch
  • Wall: 0.0625 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® - M665504NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
504NS
In Commercial Distribution

  • M665504NS1 ()
  • M665504NS0 ()

  • Lumen/Inner Diameter: 0.125 Inch
  • Outer Diameter: 0.25 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® - M665502NS0

Non Sterile Continuous Tubing
AXIOM MEDICAL, INCORPORATED
502NS
In Commercial Distribution

  • M665502NS1 ()
  • M665502NS0 ()

  • Lumen/Inner Diameter: 0.062 Inch
  • Outer Diameter: 0.095 Inch
  • Wall: 0.017 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

Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector) - M473S550SMA0

Fiber, Bare, 550um, Single Use, SMA Connector
TRIMEDYNE, INC.
S550SMA
In Commercial Distribution

  • M473S550SMA1 ()
  • M473S550SMA0 ()
S550SMA

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 550 µm Single Use Holmium Fiber - M473S5500

Fiber, Bare, 550um, Single Use, TMED Connector
TRIMEDYNE, INC.
S550
In Commercial Distribution

  • M473S55001 ()
  • M473S5500 ()
S550

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) - M473S365SMA0

Fiber, Bare, 365um, Single Use, SMA Connector
TRIMEDYNE, INC.
S365SMA
In Commercial Distribution

  • M473S365SMA1 ()
  • M473S365SMA0 ()
S365SMA

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber - M473S3650

Fiber, Bare, 365um, Single Use, TMED Connector
TRIMEDYNE, INC.
S365
In Commercial Distribution

  • M473S3651 ()
  • M473S3650 ()
S365

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector) - M473S272SMA0

Fiber, Bare, 272um, Single Use, SMA Connector
TRIMEDYNE, INC.
S272SMA
In Commercial Distribution

  • M473S272SMA1 ()
  • M473S272SMA0 ()
S272SMA

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 272 µm Single Use Holmium Bare Fiber - M473S2720

Fiber, Bare, 272um, Single Use, TMED Connector
TRIMEDYNE, INC.
S272
In Commercial Distribution

  • M473S2721 ()
  • M473S2720 ()
S272

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 200 µm Single Use Holmium Fiber (SMA Connector) - M473S200SMA0

Fiber, Bare, 200um, Single Use, SMA Connector
TRIMEDYNE, INC.
S200SMA
In Commercial Distribution

  • M473S200SMA1 ()
  • M473S200SMA0 ()
S200SMA

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 200 µm Single Use Holmium Bare Fiber - M473S2000

Fiber, Bare, 200um, Single Use, TMED Connector
TRIMEDYNE, INC.
S200
In Commercial Distribution

  • M473S2001 ()
  • M473S2000 ()
S200

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 1000 µm Single Use Fiber (SMA Connector) - M473S1000SMA0

Fiber, Bare, 1000um, Single Use, SMA Connector
TRIMEDYNE, INC.
S1000SMA
In Commercial Distribution

  • M473S1000SMA1 ()
  • M473S1000SMA0 ()
S1000SMA

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® FlexMax® 1000 µm Single Use Holmium Fiber - M473S10000

Fiber, Bare, 1000um, Single Use, TMED Connector
TRIMEDYNE, INC.
S1000
In Commercial Distribution

  • M473S10001 ()
  • M473S10000 ()
S1000

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® R-50™ Spinal Introduction Cannula - M473700520

Introducer, Spine, 1.75mm ID
TRIMEDYNE, INC.
70052
In Commercial Distribution

  • M473700521 ()
  • M473700520 ()
70052

  • Arthroscopic access cannula, single-use

Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight - M47320497HP0

Tip, Switchable, 0 degree, SJ-50
TRIMEDYNE, INC.
20497-HP
In Commercial Distribution

  • M47320497HP1 ()
  • M47320497HP0 ()
20497-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side Firing - M47320496HP0

Tip, Switchable, Omni HP System, Sidefire, SJ-90
TRIMEDYNE, INC.
20496-HP
In Commercial Distribution

  • M47320496HP1 ()
  • M47320496HP0 ()
20496-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight - M47320495HP0

Tip, Switchable, 0 degree, SJ-90
TRIMEDYNE, INC.
20495-HP
In Commercial Distribution

  • M47320495HP1 ()
  • M47320495HP0 ()
20495-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip - M47320489HP0

Ho:YAG OmniTip HP System, Sidefire, 6.5 cm
TRIMEDYNE, INC.
20489-HP
In Commercial Distribution

  • M47320489HP1 ()
  • M47320489HP0 ()
20489-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - Side Firing - M47320479HP0

Ho:YAG OmniTip HP System, Sidefire, 12.5 cm
TRIMEDYNE, INC.
20479-HP
In Commercial Distribution

  • M47320479HP1 ()
  • M47320479HP0 ()
20479-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - 60° - M47320478HP0

Tip, Switchable, Omni HP System, 60 degree
TRIMEDYNE, INC.
20478-HP
In Commercial Distribution

  • M47320478HP1 ()
  • M47320478HP0 ()
20478-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® Reposable OmniTip™ Switchable Tip - 30° - M47320476MHP0

Multiuse Switchable Tip, Omni HP System, 30 degree
TRIMEDYNE, INC.
20476M-HP
In Commercial Distribution

  • M47320476MHP1 ()
  • M47320476MHP0 ()
20476M-HP

  • General/multiple surgical laser system beam guide, reusable

Trimedyne® OmniTip™ Switchable Tip - 30° - M47320476HP0

Tip, Switchable, Omni HP System, 30 degree
TRIMEDYNE, INC.
20476-HP
In Commercial Distribution

  • M47320476HP1 ()
  • M47320476HP0 ()
20476-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® Reposable OmniTip™ Switchable Tip - 20° - M47320475MHP0

Multiuse Switchable Tip, Omni HP System, 20 degree
TRIMEDYNE, INC.
20475M-HP
In Commercial Distribution

  • M47320475MHP1 ()
  • M47320475MHP0 ()
20475M-HP

  • General/multiple surgical laser system beam guide, reusable

Trimedyne® OmniTip™ Switchable Tip - 20° - M47320475HP0

Tip, Switchable, Omni HP System, 20 degree
TRIMEDYNE, INC.
20475-HP
In Commercial Distribution

  • M47320475HP1 ()
  • M47320475HP0 ()
20475-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ Switchable Tip - Straight - M47320474HP0

Tip, Switchable, Omni HP System, 0 degree
TRIMEDYNE, INC.
20474-HP
In Commercial Distribution

  • M47320474HP1 ()
  • M47320474HP0 ()
20474-HP

  • General/multiple surgical laser system beam guide, single-use

Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle - M47320462HP0

SwitchTip, Sidefire, 25cm
TRIMEDYNE, INC.
20462-HP
In Commercial Distribution

  • M47320462HP1 ()
  • M47320462HP0 ()
20462-HP

  • General/multiple surgical laser system beam guide, single-use

Mynx Ace Vascular Closure Device (6F/7F) - M465MX67400

Mynx Ace Vascular Closure Device (6F/7F)
Access Closure, Inc.
MX6740
In Commercial Distribution

  • M465MX67400 ()
  • M465MX67401 ()

  • Catheter Gauge: 6 French
MX6740

  • Wound hydrogel dressing, non-antimicrobial

MynxGrip Vascular Closure Device (6F/7F) - M465MX67210

MynxGrip Vascular Closure Device (6F/7F)
Access Closure, Inc.
MX6721
In Commercial Distribution

  • M465MX67210 ()
  • M465MX67211 ()

  • Catheter Gauge: 6 French
MX6721

  • Wound hydrogel dressing, non-antimicrobial

MynxGrip Vascular Closure Device (5F) - M465MX50210

MynxGrip Vascular Closure Device (5F)
Access Closure, Inc.
MX5021
In Commercial Distribution

  • M465MX50210 ()
  • M465MX50211 ()

  • Catheter Gauge: 5 French
MX5021

  • Wound hydrogel dressing, non-antimicrobial

SHARP™ - M595S5120

SHARP™ Heavy-Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S512
Not in Commercial Distribution

  • M595S5121 ()
  • M595S5120 ()
S512

  • Silicone dental impression material

SHARP™ - M595S5110

SHARP™ Medium Body Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S511
Not in Commercial Distribution

  • M595S5111 ()
  • M595S5110 ()
S511

  • Silicone dental impression material

SHARP™ - M595S5100

SHARP™ Wash Premium Hydrophilic VPS Impression Material
PARKELL, INC.
S510
Not in Commercial Distribution

  • M595S5101 ()
  • M595S5100 ()
S510

  • Silicone dental impression material
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