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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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GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB87H
In Commercial Distribution

  • 50887488961734 ()
  • 10887488961736 ()
SMA36LB87H

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB878
In Commercial Distribution

  • 50197106973460 ()
  • 10197106973462 ()
SMA36LB878

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB877
In Commercial Distribution

  • 50197106565085 ()
  • 10197106565087 ()
SMA36LB877

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Uni-Gold™ C. difficile Toxin A/B, 20 Tests
MARDX DIAGNOSTICS, INC.
1206630
In Commercial Distribution

  • 05391516748773 ()
1206630

  • Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid
The Alethia™ C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the Alethia™ C. difficile test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479920
In Commercial Distribution

  • 00840733102134 ()
479920

  • Clostridium difficile nucleic acid IVD, control
The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279920
Not in Commercial Distribution

  • 00840733101120 ()
279920

  • Clostridium difficile nucleic acid IVD, control
No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8227
In Commercial Distribution

  • 70845357042711 ()
8227

  • Clostridium difficile nucleic acid IVD, control
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