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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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CARDINAL HEALTH - 10195594491758

GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB875
In Commercial Distribution

  • 50195594491756 ()
  • 10195594491758 ()
SMA36LB875

  • Laparoscopic surgical procedure kit, non-medicated, single-use

N/A - 00840329807368

B&B ABDOMINAL FLAP DEMARCATOR,
BLACK & BLACK SURGICAL, INC.
B62323
In Commercial Distribution

  • 00840329807368 ()
B62323

  • Skin marking guide, reusable

CARDINAL HEALTH - 10887488635552

STERILE GYN LAPAROSCOPIC B B
Cardinal Health 200, LLC
SMA36LB87G
In Commercial Distribution

  • 50887488635550 ()
  • 10887488635552 ()
SMA36LB87G

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10887488961736

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

  • 50887488961734 ()
  • 10887488961736 ()
SMA36LB87H

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106973462

GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB878
In Commercial Distribution

  • 50197106973460 ()
  • 10197106973462 ()
SMA36LB878

  • Laparoscopic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10197106565087

GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB877
In Commercial Distribution

  • 50197106565085 ()
  • 10197106565087 ()
SMA36LB877

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Trinity Biotech - 05391516748773

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

illumigene C. difficile External Control Kit - 00840733101120

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

Alethia™ C. difficile External Control Kit - 00840733102134

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

NATtrol™ - 01220000260061

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

NATtrol™ - 01220000260054

The NATtrol™ Clostridium difficile Positive 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 Positive 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 Positive Control
In Commercial Distribution

  • 01220000260054 ()
NATCDI-6MC-IVD

  • Clostridium difficile nucleic acid IVD, control

Echovirus Negative Control - B110ECN44100

No Description
Bion Enterprises, Ltd.
ECN-4410
Not in Commercial Distribution

  • B110ECN44100 ()
ECN-4410

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Echovirus IgG Control - B110ECG44200

No Description
Bion Enterprises, Ltd.
ECG-4420
Not in Commercial Distribution

  • B110ECG44200 ()
ECG-4420

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042711

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

QC Sets and Panels: Helix Elite™ - 70845357041370

Cepheid Xpert® C. difficile/Epi Control Panel
MICROBIOLOGICS INC.
8200 Cepheid Xpert® C. difficile/Epi Control Panel
In Commercial Distribution

  • 70845357041370 ()
8200

  • Clostridium difficile nucleic acid IVD, control

Exact Diagnostics - 00812242030734

C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control

Quidel Molecular - 30014613311089

QMol CDIFF Control Set
DIAGNOSTIC HYBRIDS, INC.
M108
In Commercial Distribution

  • 30014613311089 ()
M108

  • Clostridium difficile nucleic acid IVD, control

OrthoFlex - 00190730002341

OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002303

OrtFlx Com McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-830
In Commercial Distribution

  • 00190730002303 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001962

OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730001924

OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000644

Avalon Com Roth 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-841
In Commercial Distribution

  • 00190730000644 ()


  • Orthodontic bracket, plastic, single-use

Avalon - 00190730000460

Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, single-use

Marina Medical - 00840306812750

Deaver Scissors, Straight, B/B, 14cm
MARINA MEDICAL INSTRUMENTS, INC.
050-104
Not in Commercial Distribution

  • 00840306812750 ()
050-104

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306812729

Operating Scissors, Curved, B/B, 12.5cm
MARINA MEDICAL INSTRUMENTS, INC.
050-052
Not in Commercial Distribution

  • 00840306812729 ()
050-052

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306812712

Operating Scissors, Curved, B/B, 11.5cm
MARINA MEDICAL INSTRUMENTS, INC.
050-051A
Not in Commercial Distribution

  • 00840306812712 ()
050-051A

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306812620

Operating Scissors, Straight, B/B, 16.5cm
MARINA MEDICAL INSTRUMENTS, INC.
050-028
Not in Commercial Distribution

  • 00840306812620 ()
050-028

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306810473

Operating Scissors, Curved, B/B, 16.5cm
MARINA MEDICAL INSTRUMENTS, INC.
050-058
In Commercial Distribution

  • 00840306810473 ()

  • Length: 16.5 Centimeter
050-058

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306800269

Operating Scissors, Straight, B/B, 15.25cm
MARINA MEDICAL INSTRUMENTS, INC.
050-026
In Commercial Distribution

  • 00840306800269 ()

  • Length: 15.25 Centimeter
050-026

  • General-purpose surgical scissors, reusable

Marina Medical - 00840306800252

Operating Scissors, Straight, B/B, 12.5cm
MARINA MEDICAL INSTRUMENTS, INC.
050-024
In Commercial Distribution

  • 00840306800252 ()

  • Length,12.5,cm
050-024

  • General-purpose surgical scissors, reusable
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