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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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Pads - 00887761968936

Pad 215x100 G
Baxter Medical Systems GmbH + Co. KG
2080435
In Commercial Distribution

  • 00887761968936 ()


  • Operating table orthopaedic extension, non-powered

Polycril, MDC Dental - 07506338320177

POLYCRIL 454 g
MDC DENTAL
Polisher
In Commercial Distribution

  • 07506338320177 ()


  • Dental acrylic resin

BASE - 00887517700452

BASE Guide, G
Nuvasive, Inc.
6950307
In Commercial Distribution

  • 00887517700452 ()


  • Surgical instrument/implant depth limiter, reusable

Medline Industries, Inc. - 10198459070457

SHN G/B-NASAL-CDS-LF
MEDLINE INDUSTRIES, INC.
CDS984013D
In Commercial Distribution

  • 40198459070458 ()
  • 10198459070457 ()
CDS984013D

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

Medline Industries, Inc. - 10198459070396

SHN G/B-AAA-CDS-LF
MEDLINE INDUSTRIES, INC.
CDS984011D
In Commercial Distribution

  • 10198459070396 ()
CDS984011D

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

ACS - 00191072223357

ANGIOGRAPHY F/G
AMERICAN CONTRACT SYSTEMS, INC.
SAAN71X
In Commercial Distribution

  • 00191072223357 ()


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

BLUE AND GREEN - 00840018649101

B&G PERIOSTEAL ELEVATOR DOUBLE END G/FOX HND700
NORDENT MANUFACTURING INC
EPGF14/BG
In Commercial Distribution

  • 00840018649101 ()


  • Periosteal elevator, reusable

NeoLINER LC 1 g Kit - 00810092939276

NeoLINER LC 1 g Kit - 1 g + 15 Tips
NUSMILE, LTD.
NNLSK
In Commercial Distribution

  • 00810092939276 ()


  • Dental composite resin

Trinity Biotech - 05391516747943

FITC Mounting Medium (pH 7.5), 3.0 mL
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution

  • 05391516747943 ()
90-1610

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay

ACCURUN® - 00850041090030

No Description
Lgc Clinical Diagnostics, Inc.
2000-0102
In Commercial Distribution

  • 00850041090030 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090023

No Description
Lgc Clinical Diagnostics, Inc.
2015-0240
In Commercial Distribution

  • 00850041090023 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090016

No Description
Lgc Clinical Diagnostics, Inc.
2010-0023
In Commercial Distribution

  • 00850041090016 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00850041090009

No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

Universal Cannula - 05051223003984

The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3506
In Commercial Distribution

  • 50551223003989 ()
  • 35051223003985 ()
  • 05051223003984 ()

  • 12mm diameter x 100mm length
PS3506

  • Cardiac sizing catheter

VIROTROL - 00847661005476

VIROTROL ToRCH-M (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00117B
In Commercial Distribution

  • 00847661005476 ()
00117B

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROTROL - 00847661005445

VIROTROL ToRCH Q (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00230
In Commercial Distribution

  • 00847661005445 ()
00230

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROCLEAR - 00847661002642

VIROCLEAR ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00118
In Commercial Distribution

  • 00847661002642 ()
00118

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROTROL - 00847661002604

VIROTROL ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00109
In Commercial Distribution

  • 00847661002604 ()
00109

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000518

Liquichek ToRCH Plus IgM Control, Negative MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230NX
In Commercial Distribution

  • 00847661000518 ()
230NX

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000501

Liquichek ToRCH Plus IgM Control, Positive MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229PX
In Commercial Distribution

  • 00847661000501 ()
229PX

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000273

Liquichek ToRCH Plus IgM Control, Negative (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230
In Commercial Distribution

  • 00847661000273 ()
230

  • Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek - 00847661000266

Liquichek ToRCH Plus IgM Control, Positive (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229
In Commercial Distribution

  • 00847661000266 ()
229

  • Multiple infectious organism/newborn TORCH screen IVD, control

Tissue-Tek® Accu-Edge® - 00615233012753

Scale, Digital
SAKURA FINETEK U.S.A., INC.
0204
In Commercial Distribution

  • 00615233012753 ()
0204

  • Laboratory scale, electronic

Tissue-Tek® Accu-Edge® - 00615233012746

Scale, Economy Grade
SAKURA FINETEK U.S.A., INC.
0203
In Commercial Distribution

  • 00615233012746 ()
0203

  • Laboratory scale, mechanical

Health o meter Professional - 00854896003641

Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical

SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +) - 05055273216431

ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10350
In Commercial Distribution

  • 05055273216431 ()
SR10350

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +) - 05055273216424

ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgM Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10349
In Commercial Distribution

  • 05055273216424 ()
SR10349

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +) - 05055273216417

ToRCH IgG Positive Control is intended for use with in vitro assays for determination of IgG antibodies to Cytomegalovirus (CMV), IgG antibodies to Rubella Virus, IgG antibodies to Toxoplasma gondii, IgG antibodies to Herpes Simplex Virus Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Measles Virus, IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori IgG antibodies to Treponema pallidum (Syphilis), IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH IgG Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgG Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10348
In Commercial Distribution

  • 05055273216417 ()
SR10348

  • Multiple infectious organism/newborn TORCH screen IVD, control

SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -) - 05055273216400

ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM antibodies to Rubella virus, IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Herpes Simplex Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles), IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori, IgG antibodies to Treponema pallidum (Syphilis), IgG and IgM antibodies to the Viral Capsid Antigen of Epstein-Barr virus (EBV VCA) and IgG antibodies to the Viral Polypeptide Nuclear Antigen of Epstein-Barr Virus (EBV EBNA IgG).
RANDOX LABORATORIES LIMITED
SR10347
In Commercial Distribution

  • 05055273216400 ()
SR10347

  • Multiple infectious organism/newborn TORCH screen IVD, control

Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

AtheNA Multi-Lyte® ToRCH IgG Plus Test System - 00845533000093

The ZEUS AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV), HSV-1 and HSV-2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV-1 and HSV-2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A81101G
In Commercial Distribution

  • 00845533000093 ()
A81101G

  • Multiple infectious organism/newborn TORCH screen IVD, kit, fluorescent immunoassay

HUDSON RCI - 14026704658791

Nebulizer Adaptor 22mm O.D. x 18mm O.D.
TELEFLEX INCORPORATED
IPN029720
In Commercial Distribution

  • 24026704658798 ()
  • 14026704658791 ()
  • 04026704595525 ()
1746

  • Cardiac sizing catheter

HUDSON RCI - 14026704658784

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm O.D.
TELEFLEX INCORPORATED
IPN029719
In Commercial Distribution

  • 24026704658781 ()
  • 14026704658784 ()
  • 04026704595518 ()
1744

  • Cardiac sizing catheter

HUDSON RCI - 14026704658777

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN029718
In Commercial Distribution

  • 24026704658774 ()
  • 14026704658777 ()
  • 04026704595501 ()
1743

  • Cardiac sizing catheter

HUDSON RCI - 14026704717702

In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN916675
In Commercial Distribution

  • 24026704717709 ()
  • 14026704717702 ()
RHO743U

  • Cardiac sizing catheter

Rapid Response - 00722066000304

Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

PTS® - 04046964311055

PTS405 PTS BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613707
In Commercial Distribution

  • 04046964311055 ()
613707

  • Cardiac sizing catheter

PTS® - 04046964311031

PTS404 PTS BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613706
In Commercial Distribution

  • 04046964311031 ()
613706

  • Cardiac sizing catheter

PTS® - 04046964311017

PTS403 PTS BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613705
In Commercial Distribution

  • 04046964311017 ()
613705

  • Cardiac sizing catheter

PTS® - 04046964310997

PTS305 PTS BALLOON 30MM X 5CM X 80 CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613704
In Commercial Distribution

  • 04046964310997 ()
613704

  • Cardiac sizing catheter

PTS® - 04046964310973

PTS304 PTS BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613703
In Commercial Distribution

  • 04046964310973 ()
613703

  • Cardiac sizing catheter

PTS® - 04046964310959

PTS303 PTS BALLOON 30MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613702
In Commercial Distribution

  • 04046964310959 ()
613702

  • Cardiac sizing catheter

PTS® - 04046964310935

PTS253 PTS BALLOON 25MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613701
In Commercial Distribution

  • 04046964310935 ()
613701

  • Cardiac sizing catheter

PTS® - 04046964310911

PTS203 PTS BALLOON 20MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613700
In Commercial Distribution

  • 04046964310911 ()
613700

  • Cardiac sizing catheter

PTS-X™ - 04046964512186

PTSX406 PTSX BALLOON 40MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613752
Not in Commercial Distribution

  • 04046964512186 ()
613752

  • Cardiac sizing catheter

PTS-X™ - 04046964512179

PTSX405 PTSX BALLOON 40MM X 5CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613751
In Commercial Distribution

  • 04046964512179 ()
613751

  • Cardiac sizing catheter

PTS-X™ - 04046964512162

PTSX404 PTSX BALLOON 40MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613750
Not in Commercial Distribution

  • 04046964512162 ()
613750

  • Cardiac sizing catheter

PTS-X™ - 04046964512155

PTSX403 PTSX BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613749
In Commercial Distribution

  • 04046964512155 ()
613749

  • Cardiac sizing catheter

PTS-X™ - 04046964512148

PTSX356 PTSX BALLOON 35MM X 6CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613748
In Commercial Distribution

  • 04046964512148 ()
613748

  • Cardiac sizing catheter
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