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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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OPTIGEN Negative Control
Minaris Medical America, Inc.
82062
In Commercial Distribution

  • 00813382010099 ()
  • 00813382010310 ()
82062

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
OPTIGEN Positive Control
Minaris Medical America, Inc.
82061
In Commercial Distribution

  • 00813382010082 ()
  • 00813382010327 ()
82061

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
For the calibration of the K-ASSAY® Total IgE assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-093C
In Commercial Distribution

  • 00816426020672 ()
KAI-093C

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
IE2492
In Commercial Distribution

  • 05055273203912 ()
IE2492

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
Calibrator 80 Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995497
In Commercial Distribution

  • 00630414598246 ()
  • 00630414190716 ()
10995497

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
IgE - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10492491
In Commercial Distribution

  • 00630414580111 ()
10492491

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator
For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-092
In Commercial Distribution

  • 00816426020375 ()
KAI-092

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent
An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma
RANDOX LABORATORIES LIMITED
IE7308
In Commercial Distribution

  • 05055273203929 ()
IE7308

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent
FORCEPS SUTURING MANHATTAN E&E
Bausch & Lomb Incorporated
E1832
In Commercial Distribution

  • 00757770412471 ()
E1832

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
No Description
HYCOR BIOMEDICAL LLC
74120
Not in Commercial Distribution

  • 00816879022285 ()


  • Total immunoglobulin E (IgE total) IVD, control
  • Allergen-specific immunoglobulin E (IgE) antibody IVD, control
CUSTOM PACK BB9R81R4 E TEXAS E
MEDTRONIC, INC.
BB9R81R4
In Commercial Distribution

  • 00763000017309 ()


  • Cardiopulmonary bypass system blood tubing set
Vitamin E
Mavrik Dental System Inc.
1
In Commercial Distribution

  • 07290113770171 ()
  • 07290113770034 ()
502-01710

  • Burn gel
Abutment E
Integrum AB
1437
In Commercial Distribution

  • 07340152101310 ()
1437

  • Internal-external leg prosthesis osseointegration bar
MICROETCHER E
DANVILLE MATERIALS, LLC
20500
In Commercial Distribution

  • 00816594021556 ()
20500

  • Dental abrasive air jet system
D&E
MEDLINE INDUSTRIES, INC.
DYNJ902117
In Commercial Distribution

  • 10888277965911 ()
DYNJ902117

  • General surgical procedure kit, non-medicated, reusable
LOGIQ e
GE Medical Systems (China) Co.,Ltd.
e
In Commercial Distribution

  • 00840682103855 ()


  • General-purpose ultrasound imaging system
MDMC-32133 E
Barco NV
MDMC-32133
In Commercial Distribution

  • 05415334046511 ()
K9301401A2X

  • Radiology picture archiving and communication system workstation
E P
MEDLINE INDUSTRIES, INC.
DYNJ59726A
In Commercial Distribution

  • 10193489246261 ()
  • 40193489246262 ()
DYNJ59726A

  • General surgical procedure kit, non-medicated, single-use
E P
Cardinal Health 200, LLC
SAN31EPEV2
In Commercial Distribution

  • 50888439174142 ()
  • 10888439174144 ()
SAN31EPEV2

  • Angiography kit
LAMINECTOMY E
Cardinal Health 200, LLC
PNOCDE362
In Commercial Distribution

  • 50888439136577 ()
  • 10888439136579 ()
PNOCDE362

  • Neurosurgical procedure kit, medicated
E P
MEDLINE INDUSTRIES, INC.
DYNJ59726
In Commercial Distribution

  • 10888277777859 ()
DYNJ59726

  • General surgical procedure kit, non-medicated, single-use
D&E
MEDLINE INDUSTRIES, INC.
DYNJ902117C
In Commercial Distribution

  • 10889942845606 ()
  • 40889942845607 ()
DYNJ902117C

  • General surgical procedure kit, non-medicated, single-use
D&E
MEDLINE INDUSTRIES, INC.
DYNJ902117D
In Commercial Distribution

  • 10193489917215 ()
  • 40193489917216 ()
DYNJ902117D

  • General surgical procedure kit, non-medicated, single-use
D&E
MEDLINE INDUSTRIES, INC.
DYNJ902117A
In Commercial Distribution

  • 40889942382515 ()
  • 10889942382514 ()
DYNJ902117A

  • General surgical procedure kit, non-medicated, reusable
Orthophos E
SIRONA Dental Systems GmbH
6708429
In Commercial Distribution

  • E27667084290 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6708403
In Commercial Distribution

  • E27667084030 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707488
In Commercial Distribution

  • E27667074880 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707470
In Commercial Distribution

  • E27667074700 ()


  • Stationary panoramic dental x-ray system, digital
Orthophos E
SIRONA Dental Systems GmbH
6707462
In Commercial Distribution

  • E27667074620 ()


  • Stationary panoramic dental x-ray system, digital
E Blade
SPINEOLOGY INC.
35-06-31
In Commercial Distribution

  • M7403150014 ()
315-0014

  • Polymeric spinal interbody fusion cage
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