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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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PosiSep C 0.6 x 2.0 - 00858439001675

PosiSep C 0.6 x 2.0 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep C 0.6 x 2.0 devices were specifically engineered for use as a nasal dressing to be used following clinic based procedures.
HEMOSTASIS, LLC
9210854
In Commercial Distribution

  • 00858439001682 ()
  • 00858439001675 ()

  • Width: .64 Inch
  • Length: 2.0 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
  • Intranasal splint, non-bioabsorbable, animal-derived

ChitoGauzeXR PRO, 3in x 4yds - 00870053000568

HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053000562 ()
  • 00870053000568 ()
  • 50870053000563 ()
1020

  • Chitosan haemostatic agent, professional, non-bioabsorbable

ChitoGauzeXL, OTC, 3in x 4yd - 00870053000308

ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable

ASAHI CHIKAI X 014 soft - 04547327127691

No Description
ASAHI INTECC CO., LTD.
AIN-CKX-14-200-SFT
In Commercial Distribution

  • 04547327127691 ()

  • Length: 200 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use

WRIST STRAP 2 X 36 - 00610570058815

No Description
Bird & Cronin, LLC
S5624605
In Commercial Distribution

  • 00610570058815 ()


  • Elevation arm sling

Fluted Pin 3.10 x 90mm - 09348215058296

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-003
In Commercial Distribution

  • 09348215058296 ()


  • Fluted surgical drill bit, reusable

3/8” x ¼” Ancillary Pack - 00607567212688

No Description
DATASCOPE CORP.
BEQ-T 28906
In Commercial Distribution

  • 00607567212688 ()
709000072R01

  • Cardiopulmonary bypass system blood tubing set

Drill Pin 3.2 X 90 - 09348215058302

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-162-009
In Commercial Distribution

  • 09348215058302 ()


  • Fluted surgical drill bit, reusable

Cushion SiloLiner, 5" x 14" - 00614464016240

No Description
Silipos Holding LLC
1624
In Commercial Distribution

  • 00614464016240 ()


  • External limb prosthesis socket liner

Cushion SiloLiner, 4" x 14" - 00614464016233

No Description
Silipos Holding LLC
1623
In Commercial Distribution

  • 00614464016233 ()


  • External limb prosthesis socket liner
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