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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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Trinity Biotech - 05391516748742

EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748735

EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746199

Lyme Disease IgM IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100M
In Commercial Distribution

  • 05391516746199 ()
32-5100M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516746182

Lyme Disease IgG IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100G
In Commercial Distribution

  • 05391516746182 ()
32-5100G

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

IFA B. burgdorferi IgG/IgM Test System - 00845533001656

The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualitative and semi-quantitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This Test System should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
FA9351GM
In Commercial Distribution

  • 00845533001656 ()
FA9351GM

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Elecsys Anti-HBe - 04015630940134

Anti-HBe Elecsys E2G 300
Roche Diagnostics GmbH
07026838190
In Commercial Distribution

  • 04015630940134 ()
07026838190

  • Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 04015630911110

No Description
Roche Diagnostics GmbH
11820648122
Not in Commercial Distribution

  • 04015630911110 ()
11820648122

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 07613336175293

HBsAg Confirmatory Test Elecsys cobas e V2
Roche Diagnostics GmbH
09127127190
In Commercial Distribution

  • 07613336175293 ()
09127127190

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBsII Confirmatory - 00630414599267

HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBsAg Conf (Confirmatory) - 00630414472874

HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems HBsAg Confirmatory Kit - 00630414971544

HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems HBsAg Confirmatory Kit - 00630414947433

HBsAg Confirmatory Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706825
In Commercial Distribution

  • 00630414947433 ()
L2KCH1(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Unimed - 06945664821568

Reusable SpO2 Sensor/龙美尔/Finger clip/Adult/3.0M/111/ASMUTH
Unimed Medical Supplies, Inc.
AS98.062.28E
In Commercial Distribution

  • 06945664821568 ()


  • Pulse oximeter probe, reusable

Y-Kelin - 06943566100514

Product Name:Plaque Indicator Specification:0.3g/piece*12/box Manufacturer:Anhui Greenland Biotech Co., Ltd Address:No.5, Kaiyuan Rd,Mchekou Industrial Zone, Huaishang District,Bengbu, Anhui,China Tel:0552-5875300 Product performance:Used to show plaquue, assist oral examination and treatment Main ingredients:Erythrosine, Blue No.1 AluminumLake, Glucose, Silica, PEG-180, Magnesium Stearate, Spices Scope of application:Suitable for peoplewho are expected to show dental plaque Contraindications: 1.People who are allergic to ingredients are prohibited to use. 2.Do not swallow directly. 3.Use with caution for pregnant women and infants. Instructions: 1.Take a piece of plaque indicator into your mouth and chew it, lick it with the tip of your tongue to the inside and outside of the entire tooth surface, and hold it in your mouth for about 1 minute. 2.Spit out the residue in your mouth and rinse your mouth with water. 3. Check the oral cavity with a mirror, the stained part of the tooth surface is the part where the plaque is attached. Store: This product is stored in a ventilated and dry place at room temperature. Transportation conditions/methods:Transportation conditions and methods must meet the requirements of the instructions and signs. Period of use: Three years.
ANHUI GREENLAND BIOTECH CO.,LTD
12 Tablets
In Commercial Distribution

  • 06943566100514 ()
  • 16943566100511 ()


  • Dental caries detecting stain

EOSIN B SOLUTION - 04061837279263

No Description
Sigma-Aldrich, Inc.
2853-50ML
In Commercial Distribution

  • 04061837279263 ()


  • Foeto-maternal haemorrhage/Kleihauer test IVD, reagent

EOSIN B SOLUTION - 04061826259597

No Description
Sigma-Aldrich, Inc.
2853-100ML
In Commercial Distribution

  • 04061826259597 ()


  • Differentiation solution IVD

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking - 00886333006106

Skater™ Biliary Drainage Catheter Non-Locking Non-Locking with Radiopaque Band(12Fr x 40 cm)
ARGON MEDICAL DEVICES, INC.
12Fr x 40 cm
In Commercial Distribution

  • 20886333006100 ()
  • 00886333006106 ()

  • 12 F x 40 com
755212040

  • Biliary drain

ALBAcyte B Cells - 05060242471148

2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte B Cells, for tube techniques.
ALBA BIOSCIENCE LIMITED
Z411U
In Commercial Distribution

  • 05060242471148 ()


  • Group B Rh(D) negative reagent red blood cell IVD, antigen

C-3 Proactivator RID plate kit - B1761065

Radial immunodiffusion plate package for Human C-3 Proactivator with standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761065 ()
106511

  • Complement factor B IVD, kit precipitation/immunodiffusion

C-3 Proactivator RID plate package - B1761064

Radial immunodiffusion plate package for Human C-3 Proactivator (factor B)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761064 ()
106411

  • Complement factor B IVD, kit precipitation/immunodiffusion

Anti Human Complement C-3 Proactivator FITC - B1761062

Fluorescein conjugated polyclonal goat antiserum to Human complement C-3 Proactivator (Factor B)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761062 ()
106202

  • Complement factor B IVD, kit precipitation/immunodiffusion

Anti Human C-3 Proactivator (Factor B) - B1761060

goat antiserum to Human C-3 Proactivator
KENT LABORATORIES INC
1
Not in Commercial Distribution

  • B1761060 ()
106002

  • Complement factor B IVD, kit precipitation/immunodiffusion

TECOtherm - 04260647540314

No Description
Tec Com Medizintechnik GmbH
NEO
In Commercial Distribution

  • 04260647540314 ()
8289830

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

TECOtherm Wrabbit - 04260647540239

The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
M
In Commercial Distribution

  • 04260647540260 ()
  • 04260647540239 ()


  • Infant heat shield

TECOtherm Wrabbit - 04260647540215

The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
S
In Commercial Distribution

  • 04260647540215 ()
  • 04260647540253 ()


  • Infant heat shield

TECOtherm Wrabbit - 04260647540123

The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Tec Com Medizintechnik GmbH
L
In Commercial Distribution

  • 04260647540277 ()
  • 04260647540123 ()


  • Infant heat shield

TCmatt - 04260647540031

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOmulti
In Commercial Distribution

  • 04260647540031 ()
6426801

  • External circulating-fluid core temperature regulation system pad, reusable

TCmatt - 04260647540017

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Tec Com Medizintechnik GmbH
NEOsingle
In Commercial Distribution

  • 04260647540017 ()
  • 04260647540116 ()
6427401

  • External circulating-fluid core temperature regulation system pad, single-use

NAMIC - 10193489075182

3,PORT,KIT,COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 10193489075182 ()
  • 20193489075189 ()
650311521

  • Angiography kit

Medline Industries, Inc. - 10193489523652

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585
In Commercial Distribution

  • 10193489523652 ()
DYNJ60585

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

SpO2.COM® NRC-GE Patient Cable - 00843997001397

SpO2.COM NRC-GE Patient Cable
MASIMO CORPORATION
1854
In Commercial Distribution

  • 00843997001397 ()
1854

  • Electrical-only medical device connection cable, reusable

SpO2.COM® NRC-395 Patient Cable - 00843997001366

SpO2.COM NRC-395 Patient Cable
MASIMO CORPORATION
1811
In Commercial Distribution

  • 00843997001366 ()
1811

  • Electrical-only medical device connection cable, reusable

Medline Industries, Inc. - 10193489986297

3 PORT KIT COM HOSP
MEDLINE INDUSTRIES, INC.
650311521
In Commercial Distribution

  • 40193489986298 ()
  • 10193489986297 ()
650311521

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

CARDINAL HEALTH - 10888439513165

KIT,TOTAL KNEE, NORTHWEST COM
Cardinal Health 200, LLC
POCGTKNWM
In Commercial Distribution

  • 50888439513163 ()
  • 10888439513165 ()
POCGTKNWM

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

Medline Industries, Inc. - 10195327605544

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585C
In Commercial Distribution

  • 40195327605545 ()
  • 10195327605544 ()
DYNJ60585C

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

Medline Industries, Inc. - 10195327547776

PK CUST NEURO CABRINI COM
MEDLINE INDUSTRIES, INC.
DYNJ60585B
In Commercial Distribution

  • 40195327547777 ()
  • 10195327547776 ()
DYNJ60585B

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

Cascade Elite - 00840067100295

Cascade Elite Power/Com Module
CADWELL INDUSTRIES, INC.
190240-200
In Commercial Distribution

  • 00840067100295 ()


  • Neurophysiologic monitoring system

Easy III - 00840067100622

Easy III Power Com Module
CADWELL INDUSTRIES, INC.
190245-200
In Commercial Distribution

  • 00840067100622 ()


  • Electroencephalograph

Supremo Instrumentos - 07908854000890

Broca Coletora com Capa 7.0
ANDRE GREGATE BRAGA INSTRUMENTOS LTDA
S7923
In Commercial Distribution

  • 07908854000890 ()


  • Surgical screwdriver, reusable

Brasseler USA - 00887919801467

K0354 MCLAREN UAB COM/BISACRYL
Peter Brasseler Holdings, LLC
5026493U0
In Commercial Distribution

  • 00887919801467 ()


  • Diamond dental bur, single-use
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