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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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Retrax Pellets - 00310866000800

Hemostatic cotton pellets with aluminum sulfate
PASCAL COMPANY, INC.
12400
In Commercial Distribution

  • 00310866000800 ()
  • 00310866002019 ()
12400

  • Gingival retraction cord, medicated

SonicOne O.R. - 00841626101340

SonicOne O.R. Debridement Probe With Aspiration
MISONIX, INC.
MXC-X2-VAC
In Commercial Distribution

  • 00841626101340 ()
  • 10841626101347 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

BioPatch® - 20705031132907

BioPatch® Protective Disk with CHG
Integra Lifesciences Corporation
44151
In Commercial Distribution

  • 30705031132904 ()
  • 20705031132907 ()
  • 10705031132900 ()

  • 1.9 cm (0.75in) circumference; 1.5mm center hole


  • Exudate-absorbent dressing, non-gel, antimicrobial

BioPatch® - 20705031132914

BioPatch® Protective Disk with CHG
Integra Lifesciences Corporation
44152
In Commercial Distribution

  • 30705031132911 ()
  • 20705031132914 ()
  • 10705031132917 ()

  • 2.5 cm (1in) circumference; 7mm center hole


  • Exudate-absorbent dressing, non-gel, antimicrobial

BioPatch® - 20705031132891

BioPatch® Protective Disk with CHG
Integra Lifesciences Corporation
44150
In Commercial Distribution

  • 30705031132898 ()
  • 20705031132891 ()
  • 10705031132894 ()

  • 2.5 cm (1in) circumference; 4mm center hole


  • Exudate-absorbent dressing, non-gel, antimicrobial

Harmonic - 20705036001635

Harmonic Dissecting Hooks with Protective Sleeves-10cm
ETHICON ENDO-SURGERY, LLC
DH105
Not in Commercial Distribution

  • 30705036001632 ()
  • 20705036001635 ()
  • 10705036001638 ()
DH105

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

Dimora - 16941094064145

Silicone AG Foam Dressing with Border
Winner Medical Co., Ltd.
603-012979
In Commercial Distribution

  • 26941094064142 ()
  • 16941094064145 ()
  • 36941094064149 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

Niceful - 16941094061793

Silicone AG Foam Dressing with Border
Winner Medical Co., Ltd.
603-012980
In Commercial Distribution

  • 26941094061790 ()
  • 16941094061793 ()
  • 36941094061797 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

Dimora - 16941094025474

Silicone AG Foam Dressing with Border
Winner Medical Co., Ltd.
603-012251
In Commercial Distribution

  • 26941094025471 ()
  • 16941094025474 ()
  • 36941094025478 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

FS3 Facet Screw Spinal System - 00190837041441

FS3 Dilation Tube, #4, with Teeth
Life Spine, Inc.
2017-0001
In Commercial Distribution

  • 00190837041441 ()
2017-0001

  • Bone-screw internal spinal fixation system, non-sterile
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