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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SCATPAD SEPA 402-DT EP Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SEPA 402-DT
In Commercial Distribution

  • 10814907020460 ()
  • 00814907020463 ()
SEPA 402-DT

  • Radiation shielding panel, portable/mobile
SCATPAD SEPA 401 EP SHIELD, ATTENUATION @90kVp >75% (0.125mm), SCATTER RADIATION DRAPE
CARDIO-MEDICAL PRODUCTS, INC.
SAPA 401
In Commercial Distribution

  • 00814907020456 ()
  • 10814907020453 ()
SAPA 401

  • Radiation shielding panel, portable/mobile
SCATPAD SAFA 302 Angiography Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SAFA 302
In Commercial Distribution

  • 10814907020439 ()
  • 00814907020432 ()
SAFA 302

  • Radiation shielding panel, portable/mobile
SCATPAD SAFA 301 Angiography Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Circular Fenestration Single Level
CARDIO-MEDICAL PRODUCTS, INC.
SAFA 301
In Commercial Distribution

  • 10814907020422 ()
  • 00814907020425 ()
SAFA 301

  • Radiation shielding panel, portable/mobile
SCATPAD SMA 102 Multipurpose Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield for IR, EP, Cath Lab & OR, Dual Level
CARDIO-MEDICAL PRODUCTS, INC.
SMA 102
In Commercial Distribution

  • 10814907020347 ()
  • 00814907020340 ()
SMA 102

  • Radiation shielding panel, portable/mobile
Scatpad, Dbl. Tape, 12.5" x 16.5"
Manus Medical, LLC
SEPA 402-DT-1
In Commercial Distribution

  • 20811870037782 ()
  • 00811870037788 ()


  • Patient radiation shielding pad/drape, single-use
Posterior Cleanflow Matrices (10 Pack)
SONENDO, INC.
FG-013-00007
In Commercial Distribution

  • 00858395006745 ()
  • 00858395006738 ()
GW-PST-OMTX

  • Dental delivery system instrument unit, electric
Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on the premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-014-00001
In Commercial Distribution

  • 00858395006646 ()
  • 00858395006653 ()
GW-PRE-XF10

  • Dental delivery system instrument unit, electric
The APM Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading a bite registration material into the surface irregularities of the crown.
SONENDO, INC.
FG-003-00007
In Commercial Distribution

  • 00858395006455 ()
  • 00858395006219 ()
GW-APM-OMTX

  • Dental delivery system instrument unit, electric
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-001-00010
In Commercial Distribution

  • 00858395006424 ()
  • 00858395006158 ()
GW-MOL-SP10

  • Dental delivery system instrument unit, electric
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