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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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SPRAYVIT - E27664361950

Sprayvit E (R)
SIRONA Dental Systems GmbH
6436195
In Commercial Distribution

  • E27664361950 ()


  • Dental delivery system irrigation handpiece

CARDINAL HEALTH - 10195594449391

E P PK
Cardinal Health 200, LLC
SAN18EPEH9
In Commercial Distribution

  • 50195594449399 ()
  • 10195594449391 ()
SAN18EPEH9

  • Angiography kit

Medline Industries, Inc. - 10195327674717

E P PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ43402D
In Commercial Distribution

  • 40195327674718 ()
  • 10195327674717 ()
DYNJ43402D

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

Medline Industries, Inc. - 10195327575663

E P TRAY
MEDLINE INDUSTRIES, INC.
DYNJ67283B
In Commercial Distribution

  • 40195327575664 ()
  • 10195327575663 ()
DYNJ67283B

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

Medline Industries, Inc. - 10195327541675

M&E MAJOR
MEDLINE INDUSTRIES, INC.
DYNJ909238A
In Commercial Distribution

  • 10195327541675 ()
DYNJ909238A

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

Medline Industries, Inc. - 10195327541668

M&E MINOR
MEDLINE INDUSTRIES, INC.
DYNJ909237A
In Commercial Distribution

  • 10195327541668 ()
DYNJ909237A

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

Medline Industries, Inc. - 10195327541637

M&E CYSTO
MEDLINE INDUSTRIES, INC.
DYNJ909234A
In Commercial Distribution

  • 10195327541637 ()
DYNJ909234A

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

Medline Industries, Inc. - 10195327568467

M&E SHOULDER
MEDLINE INDUSTRIES, INC.
DYNJ909239A
In Commercial Distribution

  • 10195327568467 ()
DYNJ909239A

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

Medline Industries, Inc. - 10195327568450

.&E ANGIOGRAPHY PK
MEDLINE INDUSTRIES, INC.
DYNJ83812A
In Commercial Distribution

  • 40195327568451 ()
  • 10195327568450 ()
DYNJ83812A

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

Medline Industries, Inc. - 10195327541699

M&E SPINE
MEDLINE INDUSTRIES, INC.
DYNJ909241A
In Commercial Distribution

  • 10195327541699 ()
DYNJ909241A

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

Medline Industries, Inc. - 10195327637651

RR-D/E PACK
MEDLINE INDUSTRIES, INC.
DYNJ62645F
In Commercial Distribution

  • 40195327637652 ()
  • 10195327637651 ()
DYNJ62645F

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

CARDINAL HEALTH - 00885425623689

STERILE E PACK
Cardinal Health 200, LLC
SBA69EPCTB
In Commercial Distribution

  • 50885425623684 ()
  • 00885425623689 ()
SBA69EPCTB

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

CARDINAL HEALTH - 10195594368456

E P PACK
Cardinal Health 200, LLC
SANDHEPMC1
In Commercial Distribution

  • 50195594368454 ()
  • 10195594368456 ()
SANDHEPMC1

  • Angiography kit

Medline Industries, Inc. - 10198459132308

M&E MAJOR
MEDLINE INDUSTRIES, INC.
DYNJ909238B
In Commercial Distribution

  • 10198459132308 ()
DYNJ909238B

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

OptiMesh Multiplanar Expandable Interbody Fusion System - M7403150016

E Portal Tube
SPINEOLOGY INC.
32-30-08-2
In Commercial Distribution

  • M7403150016 ()
315-0016

  • Orthopaedic prosthesis implantation positioning instrument, single-use

K-ETCHANT Syringe - EKUR003253KA1

Needle tips (E)
KURARAY NORITAKE DENTAL INC.
#3253-KA
In Commercial Distribution

  • EKUR003253KA1 ()
  • EKUR003253KA0 ()


  • Dental etching solution

Ultrapak E - 00883205003744

Ultrapak E #00
ULTRADENT PRODUCTS, INC.
197
In Commercial Distribution

  • 00883205003744 ()
197

  • Gingival retraction cord, non-medicated

Ultrapak E - 00883205003737

Ultrapak E #0
ULTRADENT PRODUCTS, INC.
198
In Commercial Distribution

  • 00883205003737 ()
198

  • Gingival retraction cord, non-medicated

Ultrapak E - 00883205003720

Ultrapak E #1
ULTRADENT PRODUCTS, INC.
199
In Commercial Distribution

  • 00883205003720 ()
199

  • Gingival retraction cord, non-medicated

Ultrapak E - 00883205003713

Ultrapak E #2
ULTRADENT PRODUCTS, INC.
200
In Commercial Distribution

  • 00883205003713 ()
200

  • Gingival retraction cord, non-medicated

CARDINAL HEALTH - 10198956080874

E P PACK
Cardinal Health 200, LLC
SANDHEPMCF
In Commercial Distribution

  • 50198956080872 ()
  • 10198956080874 ()
SANDHEPMCF

  • Angiography kit

BASE - 00887517700438

BASE Guide, E
Nuvasive, Inc.
6950305
In Commercial Distribution

  • 00887517700438 ()


  • Surgical instrument/implant depth limiter, reusable

NOVEOS IgE Positive Control Pack - 00816879029543

No Description
HYCOR BIOMEDICAL LLC
63150Z
In Commercial Distribution

  • 00816879029543 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879029536

No Description
HYCOR BIOMEDICAL LLC
63155Z
In Commercial Distribution

  • 00816879029536 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Negative Control Pack - 00816879023039

No Description
HYCOR BIOMEDICAL LLC
63155
In Commercial Distribution

  • 00816879023039 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

NOVEOS IgE Positive Control Pack - 00816879023022

No Description
HYCOR BIOMEDICAL LLC
63150
In Commercial Distribution

  • 00816879023022 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

SPECIFIC IGE CONTROL KIT - 00816879022063

No Description
HYCOR BIOMEDICAL LLC
71207
Not in Commercial Distribution

  • 00816879022063 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

ImmunoCard STAT! EHEC - 00840733101366

ImmunoCard STAT! EHEC is an immunochromatographic rapid test for the qualitative detection of Shiga toxins 1 and 2 (also called Verotoxins) produced by E. coli in cultures derived from clinical stool specimens. ImmunoCard STAT! EHEC is used in conjunction with the patient’s clinical symptoms and other laboratory tests to aid in the diagnosis of diseases caused by enterohemorrhagic E. coli (EHEC) infections.
MERIDIAN BIOSCIENCE, INC.
751630
In Commercial Distribution

  • 00840733101366 ()
751630

  • Escherichia coli antibody IVD, kit, enzyme immunoassay (EIA)

IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control - 00630414984599

Specific IgE Neg - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485107
In Commercial Distribution

  • 00630414984599 ()
L2SNCCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 - 00630414984582

Specific IgE M6 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485106
In Commercial Distribution

  • 00630414984582 ()
MC6LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 - 00630414984575

Specific IgE D2 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485105
In Commercial Distribution

  • 00630414984575 ()
DC2LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 - 00630414984568

Specific IgE D1 - IMMULITE - CTL - 1x4mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10485104
In Commercial Distribution

  • 00630414984568 ()
DC1LCM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM - 00630414979519

Allergen Specific IgE CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388502
In Commercial Distribution

  • 00630414979519 ()
L2UNCVM

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005759

Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000144
In Commercial Distribution

  • 00847661005759 ()
12000144

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005742

Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000143
In Commercial Distribution

  • 00847661005742 ()
12000143

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005735

Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000142
In Commercial Distribution

  • 00847661005735 ()
12000142

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

Lyphochek - 00847661005728

Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
BIO-RAD LABORATORIES, INC.
12000141
In Commercial Distribution

  • 00847661005728 ()
12000141

  • Multiple allergen-specific immunoglobulin E (IgE) antibody IVD, control

BioFire JI Control Panel M420 - 00852720008121

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control

IgE Extended Calibrator Set - 00816879022094

No Description
HYCOR BIOMEDICAL LLC
74129
Not in Commercial Distribution

  • 00816879022094 ()
74129

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator

Specific IgE calibrator set - 00816879022087

No Description
HYCOR BIOMEDICAL LLC
74119
Not in Commercial Distribution

  • 00816879022087 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator
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