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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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Pure&Clean - 00852421007515

Wound Solutions Wound Cleanser OTC 8 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007515 ()

  • Total Volume: 8 Fluid Ounce
11WC8-Z

  • Antimicrobial wound irrigation solution

Pure&Clean - 00852421007508

Wound Solutions Wound Cleanser OTC 2 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007508 ()

  • Total Volume: 2 Fluid Ounce
11WC2-Z

  • Antimicrobial wound irrigation solution

Pure&Clean - 00852421007492

Vision Cleanse 2 oz
Pure & Clean, LLC
None
In Commercial Distribution

  • 00852421007492 ()

  • Total Volume: 2 Fluid Ounce
11VC2-Z

  • Eyelid solution

Catasyn (3oz) - 00852181005332

Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin. Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns.
SYNEDGEN, INC.
3 oz
In Commercial Distribution

  • 00852181005332 ()

  • Total Volume: 3 Fluid Ounce


  • Wound hydrogel dressing, non-antimicrobial

Moisyn Dry Mouth Oral Rinse - 00852181005141

No Description
SYNEDGEN, INC.
59.1
In Commercial Distribution

  • 00852181005141 ()


  • Artificial saliva

Moisyn Dry Mouth Oral Mist - 00852181005134

Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate
SYNEDGEN, INC.
60mL
In Commercial Distribution

  • 00852181005134 ()

  • Total Volume: 60 Milliliter


  • Artificial saliva

Moisyn Dry Mouth Oral Rinse - 00852181005097

Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate
SYNEDGEN, INC.
300mL
In Commercial Distribution

  • 00852181005097 ()

  • Total Volume: 300 Milliliter


  • Artificial saliva

Phoenix Surgical Wound Matrix Fenestrated - 00852513007430

No Description
NANOFIBER SOLUTIONS, INC.
FG-0057
In Commercial Distribution

  • 00852513007430 ()


  • Synthetic nanofiber barrier dressing

Phoenix Surgical Wound Matrix Fenestrated - 00852513007416

No Description
NANOFIBER SOLUTIONS, INC.
FG-0055
In Commercial Distribution

  • 00852513007416 ()


  • Synthetic nanofiber barrier dressing

Phoenix Surgical Wound Matrix Fenestrated - 00852513007393

No Description
NANOFIBER SOLUTIONS, INC.
FG-0053
In Commercial Distribution

  • 00852513007393 ()


  • Synthetic nanofiber barrier dressing
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