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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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No Description
Biomet Orthopedics, LLC
11-302015
In Commercial Distribution

  • 00880304468061 ()

  • 15 MM 300 MM
11-302015

  • Coated femoral stem prosthesis, modular
No Description
Biomet Orthopedics, LLC
178738
In Commercial Distribution

  • 00880304468412 ()

  • 28MM Ø
178738

  • Knee femur stem prosthesis
No Description
Biomet Orthopedics, LLC
178737
In Commercial Distribution

  • 00880304468405 ()

  • 27MM Ø
178737

  • Knee femur stem prosthesis
No Description
Biomet Orthopedics, LLC
178736
In Commercial Distribution

  • 00880304468399 ()

  • 26MM Ø
178736

  • Knee femur stem prosthesis
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
MANTA 14F Depth Locator
ESSENTIAL MEDICAL, INC.
IPN928169
In Commercial Distribution

  • 10856279007366 ()
  • 00856279007369 ()

  • Catheter Gauge: 14 French
114F

  • Femoral artery closure plug/patch, collagen
MANTA 8F Depth Locator
ESSENTIAL MEDICAL, INC.
IPN928168
In Commercial Distribution

  • 10856279007342 ()
  • 00856279007345 ()

  • Catheter Gauge: 8 French
188F

  • Femoral artery closure plug/patch, collagen
No Description
ESSENTIAL MEDICAL, INC.
114F
In Commercial Distribution

  • 00856279007215 ()
  • 00856279007208 ()


  • Femoral artery closure plug/patch, collagen
18F MANTA Vascular Closure Device
ESSENTIAL MEDICAL, INC.
2115
In Commercial Distribution

  • 00856279007062 ()
  • 00856279007093 ()


  • Femoral artery closure plug/patch, collagen
14F MANTA Vascular Closure Device
ESSENTIAL MEDICAL, INC.
IPN928167
In Commercial Distribution

  • 10856279007328 ()
  • 00856279007321 ()

  • Catheter Gauge: 14 French
2156

  • Femoral artery closure plug/patch, collagen
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