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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MOUTH GUARD REST ASSURED W/TRAY
KROGER CO., THE
SQN
In Commercial Distribution

  • 10041260371469 ()
  • 00041260371462 ()
  • 80041260371468 ()


  • Mouthguard, reusable
Rest Assured Mouth Guard
RITE AID CORPORATION
SQN
In Commercial Distribution

  • 80011822768869 ()
  • 00011822768863 ()


  • Mouthguard, reusable
No Description
McKeon Products, Inc.
Nighttime Dental Guard
In Commercial Distribution

  • 00033732010306 ()
1030

  • Mouthguard, reusable
Rest Assured Dental Protector for nightime grinding 2 nite protectors, 1 storage case, 1 fitting tray
RITE AID CORPORATION
SQN5483C1
In Commercial Distribution

  • 40011822768861 ()
  • 10118227688639 ()
  • 20118227688636 ()
  • 30118227688633 ()


  • Mouthguard, reusable
Grind No More Classic Dental Guard 2 Dental Guards, Storage Case and Fitting Tray SQN5485C1
AMAZON.COM SERVICES LLC
SQN54
In Commercial Distribution

  • 10195515045244 ()
  • 00195515045247 ()
  • 20195515045241 ()


  • Mouthguard, reusable
Device to alleviate pain caused by bruxing or clenching of teeth
Prismatik Dentalcraft, Inc
COMSPL
In Commercial Distribution

  • D745COMSPL0 ()
COMSPL

  • Mouthguard, reusable
The exsalt PT7 Contact Layer contains silver that inhibits bacterial growth in the dressing, as shown in-vitro for up to 7 days against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumanii. The exsalt PT7 Contact Layer consists of three layers: Two non adherent polyethylene mesh wound contact layers and an absorbent core made of polyester; all three layers are silver coated. The concentration of silver on the exsalt PT7 Contact Layer is approximately 0.4 mg/cm2 (4.5% w/w). The exsalt PT7 Contact layer meets pyrogen limit specifications. The exsalt PT7 Contact Layer is indicated for use in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts, and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Exciton Technologies Inc
PN-09-0130
In Commercial Distribution

  • 07540127000536 ()
  • 07540127000529 ()
  • 07540127000543 ()

  • Area/Surface Area: 1680 Square centimeter
CL0466

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0066
In Commercial Distribution

  • 07540127000505 ()
  • 07540127000499 ()
  • 07540127000512 ()

  • Area/Surface Area: 512 Square inch
CL1632

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0065
In Commercial Distribution

  • 07540127000444 ()
  • 07540127000437 ()
  • 07540127000451 ()

  • Area/Surface Area: 256 Square inch
CL1616

  • Wound-nonadherent dressing, absorbent, antimicrobial
The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second-degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and graft wounds. The exsalt™ PT7 Contact Layer maintains its antibacterial activity for up to seven days as shown in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii. Silver in the exsalt™ PT7 Contact Layer inhibits bacterial growth in the dressing.
Exciton Technologies Inc
PN-09-0064
In Commercial Distribution

  • 07540127000413 ()
  • 07540127000406 ()
  • 07540127000420 ()

  • Area/Surface Area: 128 Square inch
CL0816

  • Wound-nonadherent dressing, absorbent, antimicrobial
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