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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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HYBENX Root Canal Cleanser - 00860004740308

EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.
Epien Medical, Inc.
101-2002
Not in Commercial Distribution

  • 00860004740308 ()

  • Total Volume: 2 Milliliter


  • Dental mouthwash

BIASURGE™ Advanced Surgical Solution - 00850017274006

BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The product contains PHMB as a preservative to reduce microbial growth within the packaging during shelf storage after the sterile seal has been broken.
Sanara Medtech Inc.
BAS-0101
In Commercial Distribution

  • 00850017274006 ()
  • 10850017274003 ()


  • Antimicrobial wound irrigation solution

Saljet - 70188151000007

Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 20 HCL
In Commercial Distribution

  • 00188151000008 ()
  • 70188151000007 ()
  • 80188151000004 ()


  • Non-antimicrobial wound irrigation solution, saline

Saljet - 50188151000003

Saljet is a single use disposable polymer vial with a twist off top containing 30ml of sterile normal saline 0.9% w/v. It contains no preservatives, surfactants or buffering. The vials are packed into a shelf carton. Twenty vials per carton.
WINCHESTER LABORATORIES LLLP
Saljet 20
In Commercial Distribution

  • 60188151000000 ()
  • 50188151000003 ()
  • 00188151000015 ()


  • Non-antimicrobial wound irrigation solution, saline

VOCO Retraction Paste - E22110131

Material for the temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g. analogue or digital impressions, cementation of temporary and permanent restorations or preparation of class II and V fillings.
VOCO GmbH
1013
In Commercial Distribution

  • E22110130 ()
  • E22110131 ()
1013

  • Gingival retraction solution

VOCO Retraction Paste - E22110141

Material for the temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g. analogue or digital impressions, cementation of temporary and permanent restorations or preparation of class II and V fillings.
VOCO GmbH
1014
In Commercial Distribution

  • E22110141 ()
1014

  • Gingival retraction solution

VOCO Retraction Paste - E22110121

Material for the temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g. analogue or digital impressions, cementation of temporary and permanent restorations or preparation of class II and V fillings.
VOCO GmbH
1012
In Commercial Distribution

  • E22110121 ()
  • E22110120 ()
1012

  • Gingival retraction solution

NexFoam - 00858439001453

The Hemostasis NexFoam topical hemostat sponge is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9110254
In Commercial Distribution

  • 00858439001606 ()
  • 00858439001453 ()

  • Length: 1.9 Inch
  • Width: 0.6 Inch


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

NuForra - 00198715991772

NuForra Surgical Wound Care consists of fibrous, Type I bovine collagen intended for the management of surgical wounds and a wide range of acute and chronic wounds. NuForra is designed to support a moist wound environment to promote natural healing. Indications for Use: Indicated for surgical wounds, partial- and full-thickness wounds, pressure ulcers (Stages I-IV), venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis ulcers, diabetic ulcers, first- and second-degree burns, cuts, and abrasions. NuForra is suitable for application to surgical incision sites and wounds.
KAIROS BIOSCIENCES LLC
NUF-300
In Commercial Distribution

  • 00198715991772 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial

Endoform™ Antimicrobial Restorative Bioscaffold - 09421906017502

Endoform™ Antimicrobial is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue and incorporating approximately 12 ug/cm2 (~0.3% w/w) ionic silver, intended to inhibit colonization of the device. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with exudate or sterile saline, Endoform Antimicrobial transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.
AROA BIOSURGERY LIMITED
629311
In Commercial Distribution

  • 09421906017571 ()
  • 09421906017502 ()

  • 5 x 5 cm - 2 x 2"


  • Animal-derived wound matrix dressing
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