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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Hologic GAS Plasmid Control.
Hologic, Inc.
LBLD, GAS PLASMID (UNASSAYED CONTROL)
In Commercial Distribution

  • 15420045511552 ()
PRD-05052

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control
No Description
Microgenics Corporation
100012
In Commercial Distribution

  • 00884883001299 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 20884450309418 ()
  • 10884450309411 ()
  • 00884450309414 ()
001-300/A

  • Luer-formatted disinfection cap
SafeBreak Vascular is a Force-Activated Separation Device. It is intended to separate when excessive tension is exerted across a peripheral IV administration set. When SafeBreak Vascular separates, fluid flow is stopped from the infusion pump and blood flow is stopped from the patient’s IV catheter. SafeBreak Vascular is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. SafeBreak Vascular is intended to be used on peripheral IV catheters in adults and adolescent populations eighteen (18) years of age and older receiving intermittent or continuous infusions with an electronic pump.
Lineus Medical
A
In Commercial Distribution

  • 10860635000311 ()
2855-01-0001

  • Luer/Luer breakaway connector
AEON-C Stand Alone; PEEK/TAV; 15x18; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835381 ()
CSA.15180705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H15
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835374 ()
CSA.15180015

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835367 ()
CSA.15180014

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H13
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835350 ()
CSA.15180013

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835343 ()
CSA.15180012

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H11
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835336 ()
CSA.15180011

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H10
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835329 ()
CSA.15180010

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835312 ()
CSA.15180009

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H8
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835305 ()
CSA.15180008

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835299 ()
CSA.15180007

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H6
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835282 ()
CSA.15180006

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 15x18; 0deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835275 ()
CSA.15180005

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H15
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835268 ()
CSA.14161515

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835251 ()
CSA.14161514

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H13
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835244 ()
CSA.14161513

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835237 ()
CSA.14161512

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H11
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835220 ()
CSA.14161511

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H10
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835213 ()
CSA.14161510

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835206 ()
CSA.14161509

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H8
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835190 ()
CSA.14161508

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835183 ()
CSA.14161507

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H6
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835176 ()
CSA.14161506

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 15deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835169 ()
CSA.14161505

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H15
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835152 ()
CSA.14160715

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835145 ()
CSA.14160714

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H13
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835138 ()
CSA.14160713

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835121 ()
CSA.14160712

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H11
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835114 ()
CSA.14160711

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H10
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835107 ()
CSA.14160710

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835091 ()
CSA.14160709

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H8
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835084 ()
CSA.14160708

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H7
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835077 ()
CSA.14160707

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H6
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835060 ()
CSA.14160706

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 7deg; H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835053 ()
CSA.14160705

  • Spinal fixation plate, non-bioabsorbable
AEON-C Stand Alone; PEEK/TAV; 14x16; 0deg; H15
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039835046 ()
CSA.14160015

  • Spinal fixation plate, non-bioabsorbable
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