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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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Medzah Aluminum Crutches Small - 00860009370609

No Description
Medzah Industries
LYN-0814-01
In Commercial Distribution

  • 10860009370606 ()
  • 00860009370609 ()


  • Axillary crutch

INNOVATION LINE - 00860009239647

BANDAGE DISPENSER WITH BANDAGES
Innovation Specialties
5256
In Commercial Distribution

  • 00860009239647 ()


  • Pressure bandage, non-latex, single-use

K-CHECK CONTROLS - 00860009154025

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

K-CHECK - 00860009154001

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

UpLyft - 00860009140509

Patient Transfer System
PATHWAY, LLC
ST-120
In Commercial Distribution

  • 00860009140509 ()


  • Mobile patient lifting system, electrically-powered

Audien Hearing - 00860009028067

No Description
Budget Hearing Aids, LLC
Audien ion
In Commercial Distribution

  • 00860009028067 ()


  • Air-conduction hearing aid, canal

Audien Hearing - 00860009028050

No Description
Budget Hearing Aids, LLC
Audien BTE
In Commercial Distribution

  • 00860009028050 ()


  • Air-conduction hearing aid, canal

Audien Hearing - 00860009028043

No Description
Budget Hearing Aids, LLC
Atom Pro 2
In Commercial Distribution

  • 00860009028043 ()


  • Air-conduction hearing aid, canal

Audien Hearing - 00860009028036

No Description
Budget Hearing Aids, LLC
Atom 2
In Commercial Distribution

  • 00860009028036 ()


  • Air-conduction hearing aid, canal

Wearable Patch - 00860008806017

A disposable patch that temporarily adheres to the patient’s sternum, allowing for the housing of the Atlas Sensor
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806017 ()
  • 10860008806014 ()
  • 20860008806011 ()
  • 30860008806018 ()


  • Wearable multiple physiological parameter recorder, reusable
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