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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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A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 5 ml vials.
STRECK, INC.
213362
In Commercial Distribution

  • 20844509000826 ()
  • 00844509000822 ()

  • Total Volume: 5.0 Milliliter
213362

  • Evacuated blood collection tube IVD, K3EDTA
MONOCENTRIC BRAKE KNEE JOINT WITH STANCE FLEXION AND MANUAL LOCK
CYPRESS ADAPTIVE, LLC
CA602-ML
In Commercial Distribution

  • 00850013242306 ()
CA602-ML

  • Single-axis stabilizing knee prosthesis
Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump
Frontier Therapeutics Inc
6550100
In Commercial Distribution

  • 05056279302432 ()


  • Heel protector
Level 3 Procedure Face Mask with Ear Loops - 3 Layers
Blackbriar Regulatory Services, LLC
850021617561
In Commercial Distribution

  • 00850021617578 ()
  • 00850021617561 ()
BRS3561

  • Surgical/medical face mask, single-use
BritePro Omni Single-Use Laryngoscope Mini Handle With Miller Ultra 1
FLEXICARE MEDICAL LIMITED
040-06-2010U
In Commercial Distribution

  • 05055931100461 ()


  • Rigid intubation laryngoscope, single-use
2.0mm, L Plates 23mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3008-SP
In Commercial Distribution

  • 00845694047470 ()
210-3008-SP

  • Craniofacial fixation plate kit, non-bioabsorbable
2.0mm, L Plates 18mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3007-SP
In Commercial Distribution

  • 00845694044820 ()
210-3007-SP

  • Craniofacial fixation plate kit, non-bioabsorbable
2.0mm, L Plates 15mm Rigid, Left & Right, with Screws, Sterile
OSTEOMED LLC
210-3006-SP
In Commercial Distribution

  • 00845694044813 ()
210-3006-SP

  • Craniofacial fixation plate kit, non-bioabsorbable
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx
Freudenberg Medical, LLC
PK 2104
In Commercial Distribution

  • 00848253003436 ()


  • Transcervical artificial larynx
  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Binocular indirect ophthalmoscope with a camera system to record images
NEITZ INSTRUMENTS CO.,LTD.
IO-a LED CAMERA
In Commercial Distribution

  • 04571328642303 ()
205021

  • Indirect binocular ophthalmoscope, line-powered
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