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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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DC Safety - 00816058013240

FAK
DC Safety Sales
Q 4 86 0026
In Commercial Distribution

  • 20816058013244 ()
  • 00816058013240 ()
Q 4 86 0026

  • Medical bag

Q-Care Rx - 00618029830463

Q Care, Q2 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse and 0.12% Chlorhexidine Gluconate Oral Rinse
SAGE PRODUCTS, LLC
6922-B
Not in Commercial Distribution

  • 50618029830468 ()
  • 00618029830463 ()
6922-B

  • Oral care kit, single-use
  • Basic manual toothbrush
  • Dental suction system cannula, single-use
  • Oral care swab
  • Dental tooth-cleaning solution

HYGITECH - 03615140003414

This polyethylene x-ray bouffant cover will offer maximum protection against cross-contamination when covering your x-ray material, microscopes or dental lights. Internal diameter: 20cm. External diameter: 50cm.
HYGITECH
HY-63115
In Commercial Distribution

  • 03615140003421 ()
  • 03615140003414 ()
  • 03615140003438 ()
HY-63115

  • Surgical dressing/drape kit, single-use

Eagle Eyes - 00810712013621

12006 GNM Freedom Set Offer #1 (1) Freedom Flash GNM/SLV 55mm or 52mm - Polarized Sunglasses (1) Aviator NL - Night-Lite® Yellow Non-Polarized Glasses and accessories
Eagle Eyes
12006SET
In Commercial Distribution

  • 00810712013621 ()
12006SET

  • Tinted non-prescription spectacle lens

Blue Diamond - 15060797552009

Blue Diamond® Arthroscopic Leg Insert Gel Pad is desgined to wrap around a patients thight and offer pressure reduction when in an arthroscopic leg holder.
David Scott Company
BD2500
In Commercial Distribution

  • 15060797552009 ()

  • Width: 2 Inch
  • Length: 24 Inch
  • Height: .5 Inch
BD2500

  • Operating table patient pressure distribution pad, reusable

Pneumococcus Pool Q serum, 1 mL - 05713106167403

Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
16740
In Commercial Distribution

  • 05713106167403 ()
16740

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody

Monovalent Flagella Salmonella Antisera - Factor q - 05060472462473

A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6131
In Commercial Distribution

  • 05060472462473 ()
PL.6131

  • Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical

ELISA VZV IgM Q Test System - 00845533001311

The ZEUS ELISA Varicella-Zoster Virus (VZV) IgM Test System is intended for the qualitative detection of VZV IgM antibody in human sera as an aid in the diagnosis of primary infection or reactivation. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals. The assay performance in detecting antibodies to VZV in cord blood and neonates has not been established.
ZEUS SCIENTIFIC, INC.
Q9Z9331MB
In Commercial Distribution

  • 00845533001311 ()
Q9Z9331MB

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA VZV IgG Q Test System - 00845533001281

The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. This test is intended for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9331GB
In Commercial Distribution

  • 00845533001281 ()
Q9Z9331GB

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Mumps IgG Q Test System - 00845533000888

The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of Mumps infections.
ZEUS SCIENTIFIC, INC.
Q9Z9281GB
In Commercial Distribution

  • 00845533000888 ()
Q9Z9281GB

  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Measles IgG Q Test System - 00845533000826

The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9271GB
In Commercial Distribution

  • 00845533000826 ()
Q9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgM Q Test System - 00845533000505

The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human sera. The Test System is intended to be used for the diagnosis of EBV-associated infectious mononucleosis when used in conjunction with other EBV serological assays. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9201MB
In Commercial Distribution

  • 00845533000505 ()
Q9Z9201MB

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA CMV IgG Q Test System - 00845533000383

The ZEUS ELISA Cytomegalovirus (CMV) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibodies to cytomegalovirus in human serum. This test is intended to be used to evaluate serologic evidence of previous or primary infection with CMV.
ZEUS SCIENTIFIC, INC.
Q9Z9501GB
In Commercial Distribution

  • 00845533000383 ()
Q9Z9501GB

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA Rubella IgG Q Test System - 00845533001014

The ZEUS ELISA Rubella IgG Test System is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9801GB
In Commercial Distribution

  • 00845533001014 ()
Q9Z9801GB

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-EA IgG Q Test System - 00845533000536

The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9481G
In Commercial Distribution

  • 00845533000536 ()
Q9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

ELISA EBV-VCA IgG Q Test System - 00845533000475

The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9201GB
In Commercial Distribution

  • 00845533000475 ()
Q9Z9201GB

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)

ELISA EBNA-1 IgG Q Test Sytem - 00845533000444

The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9461GB
In Commercial Distribution

  • 00845533000444 ()
Q9Z9461GB

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

E&Q Master / Pen tip [XF] - 08806387890393

Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9039
Not in Commercial Distribution

  • 08806387890393 ()


  • Endodontic obturation system

E&Q Master / Pen tip [M] - 08806387890379

Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9037
Not in Commercial Distribution

  • 08806387890379 ()


  • Endodontic obturation system

E&Q Master / Pen tip [FM] - 08806387890362

Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9036
Not in Commercial Distribution

  • 08806387890362 ()


  • Endodontic obturation system

E&Q Master / Pen tip [F] - 08806387890355

Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9035
Not in Commercial Distribution

  • 08806387890355 ()


  • Endodontic obturation system

E&Q Master / Pen tip [ML] - 08806387890386

Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9038
Not in Commercial Distribution

  • 08806387890386 ()


  • Endodontic obturation system

Hose, 3' PB N2O Q/C - 00813830021981

No Description
ACCUTRON, INC.
34071
In Commercial Distribution

  • 00813830021981 ()
34071

  • Nitrous oxide quick-connect coupling, male

Recessed Schrader Q/C Outlet Nitrogen - 00813830021714

No Description
ACCUTRON, INC.
34010-S
In Commercial Distribution

  • 00813830021714 ()
34010-S

  • Medical gas pipeline system

AM- CHOLE KIT- PORT MAC Q - 30607915120499

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K0592
In Commercial Distribution

  • 30607915120499 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Ligation clip, metallic

Matrx N2O-O2 Q/C Hose Set______ft - 90813830020147

No Description
ACCUTRON, INC.
34368-CUSTOM
Not in Commercial Distribution

  • 90813830020147 ()
34368-CUSTOM

  • Nitrous oxide quick-connect coupling, male

OxyQuip N2O-O2 Q/C Hose _____ft. - 90813830020123

No Description
ACCUTRON, INC.
34168-CUSTOM
Not in Commercial Distribution

  • 90813830020123 ()
34168-CUSTOM

  • Nitrous oxide quick-connect coupling, male

OxyQuip O2 Q/C Hose _______Ft. - 90813830020062

No Description
ACCUTRON, INC.
34072-CUSTOM
Not in Commercial Distribution

  • 90813830020062 ()
34072-CUSTOM

  • Nitrous oxide quick-connect coupling, male

Accutron O2 Q/C Hose _____________FT - 90813830020048

No Description
ACCUTRON, INC.
34070-CUSTOM
Not in Commercial Distribution

  • 90813830020048 ()
34070-CUSTOM

  • Nitrous oxide quick-connect coupling, male

Proxeo ULTRA Handpiece PB-5 L Q - J021303280001

Handpiece for Proxeo ULTRA
W & H Dentalwerk Bürmoos GmbH
30328000
In Commercial Distribution

  • J021303280000 ()
  • J021303280001 ()


  • Dental ultrasonic surgical system handpiece
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