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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No Description
REMEL EUROPE LIMITED
R30859001
In Commercial Distribution

  • 05056080501581 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858701
In Commercial Distribution

  • 05056080501574 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859602
In Commercial Distribution

  • 05056080500997 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859502
In Commercial Distribution

  • 05056080500980 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30859203
In Commercial Distribution

  • 05056080500973 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R30858801
In Commercial Distribution

  • 05056080500966 ()


  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Specimen Buffer Solution
BECTON, DICKINSON AND COMPANY
256391
Not in Commercial Distribution

  • 00382902563914 ()

  • Total Volume: 8 Milliliter
256391

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Group B Strep Test
BECTON, DICKINSON AND COMPANY
255460
Not in Commercial Distribution

  • 00382902554608 ()
255460

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Cards
BECTON, DICKINSON AND COMPANY
252480
Not in Commercial Distribution

  • 00382902524809 ()
252480

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Combo Test Kit
BECTON, DICKINSON AND COMPANY
252360
Not in Commercial Distribution

  • 00382902523604 ()
252360

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ H. influenzae type b Test
BECTON, DICKINSON AND COMPANY
252260
Not in Commercial Distribution

  • 00382902522607 ()
252260

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ S. pneumoniae Test
BECTON, DICKINSON AND COMPANY
251960
Not in Commercial Distribution

  • 00382902519607 ()
251960

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
BECTON, DICKINSON AND COMPANY
250160
Not in Commercial Distribution

  • 00382902501602 ()
250160

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
BD Directigen™ Meningitis Test Negative Control Reagent
BECTON, DICKINSON AND COMPANY
252350
Not in Commercial Distribution

  • 30382902523506 ()
  • 00382902523505 ()

  • Total Volume: 9 Milliliter
252350

  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB87I
In Commercial Distribution

  • 50195594173836 ()
  • 10195594173838 ()
SMA36LB87I

  • Laparoscopic surgical procedure kit, non-medicated, single-use
STERILE B/B CURVED SCISSOR
CENTURION MEDICAL PRODUCTS CORPORATION
67025
In Commercial Distribution

  • 70653160039442 ()
  • 00653160039443 ()
67025

  • General-purpose surgical scissors, single-use
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB875
In Commercial Distribution

  • 50195594491756 ()
  • 10195594491758 ()
SMA36LB875

  • Laparoscopic surgical procedure kit, non-medicated, single-use
GYN LAPAROSCOPIC B B PACK
Cardinal Health 200, LLC
SMA36LB874
In Commercial Distribution

  • 50195594409867 ()
  • 10195594409869 ()
SMA36LB874

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

  • 50887488635550 ()
  • 10887488635552 ()
SMA36LB87G

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

  • 00190730002303 ()


  • 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
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 MD
TETRA MEDICAL SUPPLY CORP.
4015P2
In Commercial Distribution

  • 00614138115019 ()
4015P2

  • 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
Operating Scissors 5" cvd b/b
GSOURCE LLC
gS 13.4016
In Commercial Distribution

  • 00840314201607 ()
gS 13.4016

  • Bandage scissors, reusable
Operating Scissors 5" str b/b
GSOURCE LLC
gS 13.4013
In Commercial Distribution

  • 00840314201577 ()
gS 13.4013

  • Bandage scissors, reusable
Reynolds Scissors 7" cvd b/b
GSOURCE LLC
gS 13.2802
In Commercial Distribution

  • 00840314201133 ()
gS 13.2802

  • General-purpose surgical scissors, reusable
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