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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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The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.
Biorex Labs LLC
1
In Commercial Distribution

  • 00860009154025 ()
B1777

  • Acetone IVD, control
The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually.
Biorex Labs LLC
1
In Commercial Distribution

  • 00860009154001 ()
B1555

  • Acetone IVD, reagent
Patient Transfer System
PATHWAY, LLC
ST-120
In Commercial Distribution

  • 00860009140509 ()


  • Mobile patient lifting system, electrically-powered
The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1mL volume) and has audible and tactile feedback upon delivery of each 0.01 mL fluid, The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with a LDS needle, size 0.24 x 9mm, for convenience. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
Lineage Biomedical, Inc.
LIN010
In Commercial Distribution

  • 00860009080539 ()
LIN010

  • General-purpose syringe/needle
The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1mL volume) and has audible and tactile feedback upon delivery of each 0.02 mL fluid, The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with a LDS needle, size 0.24 x 9mm, for convenience. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
Lineage Biomedical, Inc.
LIN02
In Commercial Distribution

  • 00860009080522 ()
LIN02

  • General-purpose syringe/needle
The NavaClick Syringe is a manually operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1mL volume) and has audible and tactile feedback upon delivery of each 0.025 mL fluid, The syringe has been designed to enhance the efficiency and precision of neurotoxin injections. The syringe has been packaged with a LDS needle, size 0.24 x 9mm, for convenience. The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
Lineage Biomedical, Inc.
LIN025
In Commercial Distribution

  • 00860009080515 ()
LIN025

  • General-purpose syringe/needle
ST BUCK EAR CURETTE BLNT STR SZ 2
CENTURION MEDICAL PRODUCTS CORPORATION
I68055
In Commercial Distribution

  • 20653160228612 ()
  • 00653160228618 ()
I68055

  • General-purpose curette
ST BUCK EAR CURETTE BLNT STR SZ 00
CENTURION MEDICAL PRODUCTS CORPORATION
I68040
In Commercial Distribution

  • 20653160228605 ()
  • 00653160228601 ()
I68040

  • General-purpose curette
ST SHAPLEIGH EAR CURETTE SIZE 2
CENTURION MEDICAL PRODUCTS CORPORATION
I68070
In Commercial Distribution

  • 20653160228582 ()
  • 00653160228588 ()
I68070

  • General-purpose curette
ST SHAPLEIGH EAR CURETTE SIZE 1
CENTURION MEDICAL PRODUCTS CORPORATION
I68060
In Commercial Distribution

  • 20653160228575 ()
  • 00653160228571 ()
I68060

  • General-purpose curette
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