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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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ScarMD Silicone Scar Gel 1g
AIM MEDICAL INC.
1g
In Commercial Distribution

  • 00860004589778 ()


  • Scar-management dressing, single-use
ScarMD Silicone Scar Gel 6g Glide
AIM MEDICAL INC.
30mL Spray
In Commercial Distribution

  • 00860004589747 ()


  • Scar management dressing, single-use, sterile
ScarMD Silicone Scar Gel 3g
AIM MEDICAL INC.
3g
In Commercial Distribution

  • 00860004589730 ()


  • Scar-management dressing, single-use
ScarMD Silicone Scar Gel 6g
AIM MEDICAL INC.
6g gel
In Commercial Distribution

  • 00860004589723 ()


  • Scar-management dressing, single-use
ScarMD silicone scar gel 15g Glide Massaging
AIM MEDICAL INC.
15 Glide
In Commercial Distribution

  • 00860004589716 ()


  • Scar-management dressing, single-use
ScarMD Silicone Scar Gel, 15g
AIM MEDICAL INC.
15g Gel
In Commercial Distribution

  • 00860004589709 ()


  • Scar-management dressing, single-use
ANNE Pediatric is a wireless vital signs monitoring platform for use on neonatal patients of any gestational age up to infants 2 years of age.
Sibel Health Inc.
SA-011
In Commercial Distribution

  • 00860004541721 ()


  • Wearable multiple physiological parameter recorder, reusable
ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
Sibel Health Inc.
SA-008
In Commercial Distribution

  • 00860004541714 ()


  • Wearable multiple physiological parameter recorder, reusable
ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
Sibel Health Inc.
SA-002
In Commercial Distribution

  • 00860004541707 ()


  • Wearable multiple physiological parameter recorder, reusable
Blood Pressure Cuff for the purpose of determining the subject's blood pressure. Designed for use on the wrist.
HUB EMERGENCY SERVICES, LLC
MT-WBPM-001
In Commercial Distribution

  • 00860004483915 ()


  • Blood pressure cuff, reusable
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