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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
SMA36LB875
In Commercial Distribution

  • 50195594491756 ()
  • 10195594491758 ()
SMA36LB875

  • Laparoscopic surgical procedure kit, non-medicated, single-use
STERILE GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB87G
In Commercial Distribution

  • 50887488635550 ()
  • 10887488635552 ()
SMA36LB87G

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB87H
In Commercial Distribution

  • 50887488961734 ()
  • 10887488961736 ()
SMA36LB87H

  • Laparoscopic surgical procedure kit, non-medicated, single-use
B&B ABDOMINAL FLAP DEMARCATOR,
BLACK & BLACK SURGICAL, INC.
B62323
In Commercial Distribution

  • 00840329807368 ()
B62323

  • Skin marking guide, reusable
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB877
In Commercial Distribution

  • 50197106565085 ()
  • 10197106565087 ()
SMA36LB877

  • 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
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
The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Clostridium difficile Negative Control
In Commercial Distribution

  • 01220000260061 ()
NATCSO-6MC-IVD

  • Clostridium difficile nucleic acid IVD, control
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