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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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Trabexus® - W4146EB0010T0475

Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft

Trabexus® - W4146EB0005T0475

Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft

Trabexus® - W4146EB0003T0475

Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft

Cora - X003852LQL

"Soft Fit Disc"
Cora
10Disc-200
In Commercial Distribution

  • X003852LQL ()


  • Menstrual cup, non-latex, reusable

Cora - X0037JBZAL

Cora Menstrual Cup Size 1 (DTC & AMZ)
Cora
10MenstrualCup-S1A
In Commercial Distribution

  • X0037JBZAL ()


  • Menstrual cup, non-latex, reusable

Cora - X0037EZAVV

Cora Disc, DTC + Amazon
Cora
10Disc-008
Not in Commercial Distribution

  • X0037EZAVV ()


  • Menstrual cup, non-latex, reusable

Cora - X002US3067

Disc, Amazon in Tins
Cora
10Disc-003
Not in Commercial Distribution

  • X002US3067 ()


  • Menstrual cup, non-latex, reusable

QuickGraft - W41844300PSTT165

QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft

DBX® - W4184428025T0473

DBX Putty 2.5cc
Musculoskeletal Transplant Foundation, Inc.
428025
In Commercial Distribution

  • W4184428025T0473 ()

  • 2.5 cc volume
428025

  • Bone matrix implant, human-derived

DBX® - W4184428010T0473

DBX Putty 1cc
Musculoskeletal Transplant Foundation, Inc.
428010
In Commercial Distribution

  • W4184428010T0473 ()

  • 1 cc volume
428010

  • Bone matrix implant, human-derived
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