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

  • 30014613311089 ()
M108

  • Clostridium difficile nucleic acid IVD, control
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
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
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 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 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
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
MALLEABLE B/B FINGER P LG
TETRA MEDICAL SUPPLY CORP.
4015P3
In Commercial Distribution

  • 00614138115026 ()
4015P3

  • Hand/finger splint, reusable
MALLEABLE B/B FINGER P SM
TETRA MEDICAL SUPPLY CORP.
4015P1
In Commercial Distribution

  • 00614138115002 ()
4015P1

  • Hand/finger splint, reusable
LEWIN B/B FINGER P UNIV
TETRA MEDICAL SUPPLY CORP.
4014PO
In Commercial Distribution

  • 00614138114999 ()
4014PO

  • Hand/finger splint, reusable
MALLEABLE B/B FINGER P MD
TETRA MEDICAL SUPPLY CORP.
4015P2
In Commercial Distribution

  • 00614138115019 ()
4015P2

  • Hand/finger splint, reusable
B&B BAYONET NH 6-3/4
BLACK & BLACK SURGICAL, INC.
B91514
In Commercial Distribution

  • 00840329833350 ()
B91514

  • Suturing needle holder, reusable
Operating Scissors 5" str b/b
GSOURCE LLC
gS 13.4013
In Commercial Distribution

  • 00840314201577 ()
gS 13.4013

  • Bandage scissors, reusable
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
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