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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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Awl with Stop
Life Spine, Inc.
113-438
In Commercial Distribution

  • 00190837035457 ()
113-438

  • Bone-screw internal spinal fixation system, non-sterile
with wrist strap
MEDTEC, INC.
20SR02SUB3
In Commercial Distribution

  • 00841439110751 ()

  • Length: 60 Inch
20SR02SUB3

  • Radiological arm/leg positioner
PCA with MedNet
HOSPIRA, INC.
20709
In Commercial Distribution

  • M3352070904871 ()

  • Height: 15.1 Inch
  • Length: 13.143 Inch
  • Depth: 11.1 Inch
20709

  • Patient-controlled analgesia infusion pump
No Description
POS-T-VAC INC
Esteem Cylinder with Insert
In Commercial Distribution

  • 00857312008183 ()
1250

  • Penile vacuum device
No Description
PROSOMNUS SLEEP TECHNOLOGIES
EVO with Patient Monitoring
In Commercial Distribution

  • 00863039000492 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Fully Automated Urine Cell Analyzer UF-1000i UF WAM
Sysmex America, Inc.
UF-1000i with UF WAM
In Commercial Distribution

  • 00664369000639 ()


  • Flow cytometry analyser IVD
Siemens UNITY 3 WITH INSERT
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERT
Not in Commercial Distribution

  • 05711781000749 ()
10824331

  • Audiometric/hearing aid tester
No Description
Natus Medical Denmark ApS
REM Tube with ruler
In Commercial Distribution

  • 05713315005701 ()


  • Hearing aid tester, electrical
1081 AURICAL (PMM, C&S) with HI-PRO (US only)
Natus Medical Denmark ApS
1081 AURICAL with HI-PRO
In Commercial Distribution

  • 05713315005527 ()
8-04-14536

  • Speech audiometer
  • Tone audiometer
No Description
Natus Medical Denmark ApS
PROBE TIP WITH TUBES
In Commercial Distribution

  • 05713315002373 ()


  • Impedance audiometer
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