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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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Winx Health Inc - 00850024942325

Vaginal pH Tests
Get Stix Inc.
1
In Commercial Distribution

  • 00850024942370 ()
  • 00850024942325 ()


  • Vaginal pH screening IVD, kit, rapid colorimetric, self-testing

Stix - 00850024942301

Condoms 12 Pack
Get Stix Inc.
1
In Commercial Distribution

  • 00850024942615 ()
  • 00850024942301 ()


  • Basic male condom, Hevea-latex

KONMED /Pelvifine - 06970935830543

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device

KONMED /Pelvifine - 06970935830536

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device

LightForce X - 00854103007295

Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional

SoLa Therapy Laser - 00854103007066

Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional

McKesson - 10612479153421

Infant Heel Warmer Heats up to 104°F with adhesive tab , Disposable 3.75"x5.5"
MCKESSON MEDICAL-SURGICAL INC.
59-45HW
In Commercial Distribution

  • 20612479153435 ()
  • 10612479153421 ()
  • 40612479153446 ()


  • Hot/cold therapy pack, single-use

OsteoMed - 00845694032735

Oracle 25mm Cranial Distractor
OSTEOMED LLC
217-1225
In Commercial Distribution

  • 00845694032735 ()

  • Distraction = up to 25mm
217-1225

  • Implantable craniofacial bone distractor

OsteoMed - 00845694032728

Oracle 20mm Cranial Distractor
OSTEOMED LLC
217-1220
In Commercial Distribution

  • 00845694032728 ()

  • Distraction = up to 20mm
217-1220

  • Implantable craniofacial bone distractor

OsteoMed - 00845694032711

Oracle 15mm Cranial Distractor
OSTEOMED LLC
217-1215
In Commercial Distribution

  • 00845694032711 ()

  • Distraction = up to 15mm
217-1215

  • Implantable craniofacial bone distractor
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