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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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SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017563

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017563 ()
A15573

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

SeCore™ DRB1 Locus Exon 2 & 3 Sequencing Kit - 00812117017556

SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017556 ()
A15571

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Lambda Antigen Tray™ Class II - 2 test tray - 00812117012476

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012476 ()
LAT240

  • HLA class I & II antibody screening IVD, kit, multiplex

Lambda Antigen Tray™ Class I - 2 test tray - 00812117012469

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117012469 ()
LAT140X2

  • HLA class I & II antibody screening IVD, kit, multiplex

Antibacterial Wound Dressing with Copper with Adhesive Contour #2 - 07290018406090

Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg & foot ulcers, pressure ulcers, first & second degree burns, surgical wounds; venous and arterial ulcers. External Size 4" x 10". Internal pad size 2" x 8"
MEDCU TECHNOLOGIES LTD
2C-1025-01a
In Commercial Distribution

  • 07290018406311 ()
  • 07290018406090 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial

Elecsys HIV Duo - 07613336183120

No Description
Roche Diagnostics GmbH
08836973162
In Commercial Distribution

  • 07613336228500 ()
  • 07613336183120 ()
08836973162

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Packing Strip - 00616784340425

Packing Strip, Plain, Sterile, 2" x 5 yd. (50.08 mm x 4.6 m)
Dynarex Corporation
3404
In Commercial Distribution

  • 00616784340425 ()
  • 00616784340432 ()


  • Gauze strip, non-antimicrobial

CoolJect Targeted-Mist Topical Anesthetic - 00860006961589

CoolJect Targeted-Mist Topical Anesthetic Canister with Integrated Nozzle (2 Wt. Oz). 1 Canister
Vapocoolshot, Inc
CJ02050-00
In Commercial Distribution

  • 00860006961589 ()


  • Cold/cool therapy spray

BIOS Living - 00057475561253

Tapered Foam Ear Plugs With Keychain 4 PC Orange 32dB with 2 Keychains
Thermor Ltd
EP125
In Commercial Distribution

  • 20057475561257 ()
  • 00057475561253 ()
  • 10057475561250 ()


  • Earplugs, single-use

CareOne - 00041520117946

Rest Assured 2 Nite Protectors, Storage Case, Fitting Tray, Custom Fitting Instructions SQN54
Ahold U.S.A., Inc.
79002
In Commercial Distribution

  • 10041520117943 ()
  • 00041520117946 ()
  • 02041520117944 ()


  • Mouthguard, reusable
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