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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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Hyper LT - 07613327289893

Angled Hard Tissue Curette Handpiece without Tip, 25 kHz
STRYKER MEDTECH K.K.
5450814000
In Commercial Distribution

  • 07613327289893 ()
5450-814-000

  • Soft-tissue ultrasonic surgical system handpiece, reusable

Procellera Single Layer - 00810198030310

Procellera Single Layer Rx 12" x 12"
Vomaris Wound Care, Inc.
12" x 12"
In Commercial Distribution

  • 00810198030358 ()
  • 00810198030310 ()
  • 00810198030365 ()
VSR-1212

  • Portable pneumatic high-frequency ventilator

CUSA® Clarity - 10381780126263

CUSA® Clarity Handpiece, Cleaning Brush
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7036
In Commercial Distribution

  • 10381780126263 ()
C7036

  • Soft-tissue ultrasonic surgical system handpiece, reusable

CUSA® Selector® - 10381780121909

CUSA® Selector® 24KHz Angled Extension Shroud
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523035
Not in Commercial Distribution

  • 10381780121909 ()

  • 24kHz Ultrasonic Frequency
1523035

  • Soft-tissue ultrasonic surgical system handpiece, reusable

MY01 Mobile Application - 07540162030093

No Description
MY01 Inc
v1.22
In Commercial Distribution

  • 07540162030093 ()


  • Compartmental-pressure monitoring system, single-use

MY01 Continuous Compartmental Pressure Monitor - 07540162030017

No Description
MY01 Inc
0001
In Commercial Distribution

  • 07540162030017 ()
  • 07540162030086 ()


  • Compartmental-pressure monitoring system, single-use

DQB SSP Kit - 07611969953295

Kit for 24 determinations of HLA-DQB alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826220
Not in Commercial Distribution

  • 07611969953295 ()
826220

  • HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

DRB SSP Kit - 07611969953288

Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use
Bio-Rad Medical Diagnostics GmbH
826215
Not in Commercial Distribution

  • 07611969953288 ()
826215

  • HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)

CARDINAL HEALTH - 00888499001049

WOUND GEL SILVER HYDROGEL ANTIMICROBIAL
Cardinal Health 200, LLC
HG15OZAG
In Commercial Distribution

  • 20888499001043 ()
  • 00888499001049 ()
  • 30888499001040 ()
HG15OZAG

  • Wound hydrogel dressing, antimicrobial

ViveCare - 00810113578514

Hemostatic Gauze (4x4")
VIVE HEALTH LLC
RHB3030S10CT
In Commercial Distribution

  • 10810113578511 ()
  • 00810113578514 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
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