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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PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices expand when hydrated providing separation between the sinus tissues.
HEMOSTASIS, LLC
9210614
In Commercial Distribution

  • 00858439001880 ()
  • 00858439001897 ()

  • Width: 0.7 Inch
  • Length: 1.7 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE PADS
Gyrus ACMI, LLC
890912
In Commercial Distribution

  • 00821925022379 ()
  • 00821925042391 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
CUSTOM NASAL SPLINT, THIN SHORT-TERM USE UP TO 14 DAYS .25 MM UHMWPE (12/PK)
Gyrus ACMI, LLC
890920
In Commercial Distribution

  • 00821925022171 ()
  • 00821925040328 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
BIVALVE SPLINT, LARGE THICK. SHORT-TERM USE UP TO 14 DAYS .50 MM UHMWPE (12/PK)
Gyrus ACMI, LLC
890919
In Commercial Distribution

  • 00821925022164 ()
  • 00821925040311 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
BIVALVE SPLINT, STANDARD THIN. SHORT-TERM USE UP TO 14 DAYS .25 MM UHMWPE (12PK)
Gyrus ACMI, LLC
890918
In Commercial Distribution

  • 00821925022157 ()
  • 00821925040304 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
BIVALVE SPLINT, STANDARD THICK. SHORT-TERM USE UP TO 14 DAYS .50 MM UHMWPE (12/PK)
Gyrus ACMI, LLC
890917
In Commercial Distribution

  • 00821925022140 ()
  • 00821925040298 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
Blu D-Style Anatomical Nasal Pack, Slim, 8.0 cm x .75 cm x 3.0 cm, Bacteriostatic
Gyrus ACMI, LLC
7089-0842
In Commercial Distribution

  • 00821925030251 ()
  • 00821925034969 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
Blu D-Style Anatomical Nasal Pack, with Airway, 8.0 cm x 1.5 cm x 3.0 Bacteriostatic
Gyrus ACMI, LLC
7089-0840
In Commercial Distribution

  • 00821925030237 ()
  • 00821925034952 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
Blu D-Style Anatomical Nasal Pack, 8.0 cm x1.5 cm x 3.0 cm, Bacteriostatic
Gyrus ACMI, LLC
7089-0838
In Commercial Distribution

  • 00821925030213 ()
  • 00821925034945 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
Blu Nasal Pack, Large, with Airway, 8.0 cm x 1.5 cm x 2.0 cm, Bacteriostatic (10/PK)
Gyrus ACMI, LLC
7089-0836
In Commercial Distribution

  • 00821925030190 ()
  • 00821925034938 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
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