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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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Geenius - 03610522162239

Geenius Blood Donor IFU & APF v2.0 binder
Bio-RAD Laboratories, Inc.
12012482
In Commercial Distribution

  • 03610522162239 ()

  • 1 each
12012482

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

Geenius - 03610521168942

Geenius HIV 1/2 Supplemental Assay 20t
Bio-RAD Laboratories, Inc.
72480
In Commercial Distribution

  • 03610521168942 ()

  • 20 Tests
72480

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

Rite Aid - 10118227688639

Rest Assured Dental Protector for nightime grinding 2 nite protectors, 1 storage case, 1 fitting tray
RITE AID CORPORATION
SQN5483C1
In Commercial Distribution

  • 40011822768861 ()
  • 10118227688639 ()
  • 20118227688636 ()
  • 30118227688633 ()


  • Mouthguard, reusable

GuardaCare® PRO, 4in x 4in, 8ply - 00870053001367

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

  • 00870053001367 ()
  • 20870053001361 ()
  • 50870053001362 ()
1013

  • Chitosan haemostatic agent, professional, non-bioabsorbable

HemCon GuardaCare® PRO, 2in x 2in, 8ply - 00870053001350

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

  • 00870053001350 ()
  • 20870053001354 ()
  • 50870053001355 ()
1012

  • Chitosan haemostatic agent, professional, non-bioabsorbable

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

ChitoGauze®XR PRO 3" x 4 yds - 00870053000131

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

  • 50870053000136 ()
  • 00870053000131 ()
1090

  • Chitosan haemostatic agent, professional, non-bioabsorbable

Harmonic ACE - 10705036014447

Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Generator G11
ETHICON ENDO-SURGERY, LLC
HAR36
In Commercial Distribution

  • 30705036014441 ()
  • 10705036014447 ()
  • 20705036014444 ()
HAR36

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

Harmonic ACE - 10705036014430

Harmonic Ace 5mm Diameter Shears 23cm Shaft length + Adaptive Tissue Technology for use with Generator G11
ETHICON ENDO-SURGERY, LLC
HAR23
In Commercial Distribution

  • 30705036014434 ()
  • 10705036014430 ()
  • 20705036014437 ()
HAR23

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® Selector® - 10381780121947

SELECTOR HANDPIECE STERILIZATION TRAY:The steriliser tray provides a convenient handling system for sterilisation of re-usable devices.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
07289
In Commercial Distribution

  • 10381780121947 ()


  • Device sterilization/disinfection container, reusable
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