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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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LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex - 10888234400035

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628917
In Commercial Distribution

  • 10888234400035 ()
628917

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B SSO Typing Kit for use with Luminex - 10888234400028

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628915
Not in Commercial Distribution

  • 10888234400028 ()
628915

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex - 10888234400011

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628913
In Commercial Distribution

  • 10888234400011 ()
628913

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A SSO Typing Kit - 10888234400004

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628911
Not in Commercial Distribution

  • 10888234400004 ()
628911

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Panoscreen EXTEND - 10888234002406

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Webcol - 10192253046205

Alcohol Prep, 2 Ply, Large, Made in USA, Saturated with 70% Isopropyl Alcohol, For external use only
Cardinal Health 200, LLC
5110
In Commercial Distribution

  • 20192253046202 ()
  • 10192253046205 ()
  • 50192253046203 ()
5110

  • Skin cleaning wipe

Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bot - 00856040008427

Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TC
In Commercial Distribution

  • 10856040008424 ()
  • 00856040008427 ()


  • Antimicrobial wound irrigation solution

EdgeEndo Sodium Hypochloite - 00818365020034

EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agents to lower surface tension.
EDGE ENDO LLC
EENAOCL
In Commercial Distribution

  • 00818365020034 ()

  • Total Volume: 480 Milliliter


  • Dental tooth-cleaning solution

PuraPly™ Wound Matrix - 00618474000077

PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-012
In Commercial Distribution


  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Collagen wound matrix dressing

PuraPly™ Wound Matrix - 00618474000060

PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-006
In Commercial Distribution

  • 00618474000060 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Collagen wound matrix dressing
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