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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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No Description
Biomedica Diagnostics Inc
10 mL
In Commercial Distribution

  • 10627944000100 ()
  • 00627944000103 ()


  • Calcium chloride coagulation reagent IVD
No Description
Biomedica Diagnostics Inc
10 mL
In Commercial Distribution

  • 00627944000059 ()


  • Activated partial thromboplastin time (APTT) IVD, reagent
No Description
Biomedica Diagnostics Inc
10 mL
In Commercial Distribution

  • 10627944000032 ()
  • 00627944000035 ()


  • Prothrombin time (PT) IVD, reagent
SCREW, CORTICAL, EXT TAB, 7.5MM X 65MM
Kalitec Direct LLC
10+-SRE-7565
In Commercial Distribution

  • B07310SRE75651 ()
10-SRE-7565

  • Spinal bone screw, non-bioabsorbable
SCREW, CORTICAL, TTAB CANN, 4.75 X 60MM
Kalitec Direct LLC
10-+SNT-4760
In Commercial Distribution

  • B07310SNT47601 ()
10-SNT-4760

  • Spinal bone screw, non-bioabsorbable
20g ACM Lewicky
STERIMEDIX LIMITED
M2657-02/10
In Commercial Distribution

  • 15056030400404 ()
  • 65056030400409 ()
M2657

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Contents: One 5mm Pilot Guide and one 10/12mm Pilot Guide
Coopersurgical, Inc.
PG-5/10
In Commercial Distribution

  • 20888937002991 ()
  • 60888937002999 ()


  • Laparoscopic wound closure thread
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
Flowtron Standard Sequential Calf Garment- fits up to 17 inch calf circumference.
RENU MEDICAL, INC
RM-TRP 10
In Commercial Distribution

  • 10816317023130 ()
  • 00816317023133 ()


  • Multi-chamber venous compression system garment, reprocessed
ProSlate Speech Generating Device
FORBES REHAB SERVICES INC
ProSlate 10
In Commercial Distribution

  • B398PS100 ()


  • Voice synthesizer/digitizer
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