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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OPTIVAC KIT DOUBLE MIX 80GM
Encore Medical, L.P.
600-50-080
In Commercial Distribution

  • 00190446138051 ()


  • Orthopaedic cement, non-antimicrobial
OPTIVAC KIT SINGLE MIX 40GM
Encore Medical, L.P.
600-50-040
In Commercial Distribution

  • 00190446138044 ()


  • Orthopaedic cement, non-antimicrobial
HiVac™ 7 Triple Mix
SUMMIT MEDICAL LIMITED
C703
In Commercial Distribution

  • 25060238201630 ()
  • 15060238201633 ()
  • 35060238201637 ()
C703

  • Orthopaedic cement preparation/delivery kit
TANK, O2, M9, Alum.
MEDSOURCE INTERNATIONAL LLC
MS-MED-M9
In Commercial Distribution

  • 00840155403529 ()
Not Applicable

  • Calibration gas/non-refillable cylinder
36 Well Test Tray
MEDSCIENCE RESEARCH GROUP, INC.
1001-36
Not in Commercial Distribution

  • B6821001360 ()
1001-36

  • General laboratory assay tray
The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use.
Tulavi Therapeutics, Inc.
TL-7627
In Commercial Distribution

  • 10860012518125 ()
  • 00860012518128 ()
TL-7627

  • Nerve cap delivery mixer/needle
OPTIVAC MAX CAPACITY SINGLE MIX (HIGH VOL CEMENT)
Encore Medical, L.P.
600-99-001
In Commercial Distribution

  • 00190446138143 ()


  • Orthopaedic cement, non-antimicrobial
Mix Avenger H,A,BW 3/4"x3"
Dukal LLC
1087937
In Commercial Distribution

  • 20665973019455 ()
  • 10665973019458 ()
  • 00665973019451 ()
1087937

  • Skin-cover adhesive strip, non-antimicrobial
Mix Avenger IM,CA,BP 3/4"x3"
Dukal LLC
1087837
In Commercial Distribution

  • 20665973019400 ()
  • 10665973019403 ()
  • 00665973019406 ()
1087837

  • Skin-cover adhesive strip, non-antimicrobial
SMITH & NEPHEW CEM MIX BOWL W/SPATULA DISPOSABLE
Smith & Nephew, Inc.
210098
In Commercial Distribution

  • 03596010101822 ()
210098

  • Orthopaedic cement mixing bowl
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