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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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RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001370A
In Commercial Distribution

  • 00840828108522 ()
2071

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001022A
In Commercial Distribution

  • 00840828108515 ()
2070

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001020A
In Commercial Distribution

  • 00840828108508 ()
2069

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-0010201
In Commercial Distribution

  • 00840828108492 ()
2068

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-000020A
In Commercial Distribution

  • 00840828108485 ()
2067

  • Pillow speaker
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00105
In Commercial Distribution

  • 10858395006476 ()
  • 00858395006479 ()
GW-MOL-SC05

  • Dental delivery system instrument unit, electric
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C412U-001020F
In Commercial Distribution

  • 00840828156226 ()
21386

  • Pillow speaker
RESPONDER 5, ENHANCED, GETWELL
CURBELL MEDICAL PRODUCTS, INC.
4C410U-701033F
In Commercial Distribution

  • 00840828156219 ()
21385

  • Pillow speaker
No Description
SALVIN DENTAL SPECIALTIES, LLC
PT-5
In Commercial Distribution

  • 00841336103740 ()


  • Bone lever/elevator, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS14559
In Commercial Distribution

  • 04049098006224 ()


  • Electrocardiographic lead set, reusable
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