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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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The MEBO Wound Dressing is a CO60 gamma-radiation sterilized dressing consisting of sesame oil, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mmx100mm
In Commercial Distribution

  • 00860005367511 ()
  • 10860005367518 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
FirstPlug Screw Channel Barrier 210cm
35newtons L.L.C.
P000017-005
In Commercial Distribution

  • 00860005367252 ()
P000017-005

  • Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-004
In Commercial Distribution

  • 00860005367238 ()
P000017-004

  • Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-003
In Commercial Distribution

  • 00860005367221 ()
P000017-003

  • Antimicrobial dental prosthesis/implant plug
FirstPlug Screw Channel Barrier 210 cm
35newtons L.L.C.
P000017-001
In Commercial Distribution

  • 00860005367207 ()
P000017-001

  • Antimicrobial dental prosthesis/implant plug
No Description
Calyxo, Inc.
CVC127020-1
In Commercial Distribution

  • 00860005357710 ()


  • Flexible video ureteroscope, single-use
  • Intracorporeal lithotripsy suction system
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution

  • 00860005178803 ()


  • Appetite-suppression gastric balloon
Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or cranial fractures in order to prioritize them for clinical review. The standalone software device consists of an on-premise module and a cloud module. qER accepts non-contrast adult head CT scan DICOM files as input and provides a priority flag indicating critical scans.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
2.0.0
In Commercial Distribution

  • 00860005118106 ()


  • Radiology DICOM image processing application software
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
No Description
WAHTS HEARING LLC
AC 1
In Commercial Distribution

  • 00860005068302 ()


  • Tone audiometer
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