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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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Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.
Clever Culture Systems AG
A
In Commercial Distribution

  • 09354646000001 ()
AI-16001

  • Microbial culture plate imaging/analysis system IVD
To provide support for a patient’s head in the prone position.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187718 ()
AM0710

  • Operating table patient positioning set, reusable
Head Immobiliser Hood Assembly and Strap
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187657 ()
AM0820

  • Operating table patient positioning set, reusable
Adducted Arm Scoop
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187640 ()
AM1100

  • Radiological arm/leg positioner
To support the Clinicians arm during endoscope guided surgery.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187619 ()
AM0900

  • Operator armrest
Head Immobiliser
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187602 ()
AM0800

  • Operating table patient positioning set, reusable
To provide a support surface for patient’s arm and head in prone position.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187596 ()
M0700

  • Operating table patient positioning set, reusable
Arm Support Pad for STARBoard Arm Rest and Clinician Arm Support
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187558 ()
AM0171

  • Radiological arm/leg positioner
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "A" is labeled for connections to electrodes 1-64.
NEURALYNX, INC.
-A
In Commercial Distribution

  • 00850011306369 ()
31-0602-0032

  • Electrical-only medical device connection cable, reusable
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