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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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CVS Health - 00050428259726

Flexible Fabric Antibacterial Bandages, assorted sizes, 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 3/4 IN x 3 IN (19 mm x 76 mm), 1 IN x 3 IN (25 mm x 76 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
875951
In Commercial Distribution

  • 10050428259723 ()
  • 00050428259726 ()


  • Skin-cover adhesive strip, antimicrobial

CVS Health - 00050428256176

Flexible Fabric, Antibacterial Bandages, Assorted sizes, 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 3/4 IN x 3 IN ( 19 mm x 76 mm), 1 IN x 3 IN (25 mm x 76 mm)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
951344
In Commercial Distribution

  • 10050428256173 ()
  • 00050428256176 ()


  • Skin-cover adhesive strip, antimicrobial

Antibacterial Wound Dressing with Copper with Adhesive Contour #1 - 07290018406076

Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg & foot ulcers, pressure ulcers, first & second degree burns, surgical wounds; venous and arterial ulcers. External Size 4" x 4". Internal pad size 2" x 2.2"
MEDCU TECHNOLOGIES LTD
2C-0505-01a
In Commercial Distribution

  • 07290018406298 ()
  • 07290018406076 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial

ACTEON - 03760243000959

HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use.
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl Kit
Not in Commercial Distribution

  • 03760243000959 ()
246200

  • Non-organic haemostatic agent

CHX Plus - 10818207020359

Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifiers to improve the depth of penetration and kills bacteria. 30ml Bulk Syringe Kit Includes: (1) 30mL prefilled bulk syringe, (20) 1.2cc syringes, (20) 27ga side-vent irrigating tips & (1) docking port.
Vista Dental
503400
In Commercial Distribution

  • 10818207020359 ()


  • Root canal cleaning solution

CHX Plus - 10818207020342

Contains 2% Chlorhexidine Gluconate plus powerful wetting agents and proprietary surface modifiers to improve the depth of penetration and kill bacteria. Use prior to restorative preparations of crowns and composites. 30mL Bulk Syringe Includes: (1) 30mL prefilled bulk syringe & (1) docking port
Vista Dental
503650
In Commercial Distribution

  • 10818207020342 ()


  • Root canal cleaning solution

Kerecis® Omega3 BURN - 05694310961110

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Mesh ratio 2:1 Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310961127 ()
  • 05694310961110 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202N21D0D

  • Collagen wound matrix dressing

TempoSmart - B553TEMPOSMART110

TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution

  • B553TEMPOSMART110 ()


  • Home pharmaceutical management support software

TempoSmart - B553TEMPOSMART100

TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution

  • B553TEMPOSMART100 ()


  • Home pharmaceutical management support software

Comfortear™ - 10810003223583

Comfortear™ Punctum Plugs are packaged sterile and pre-loaded individually on the ergonomically designed Comfortear™ Insertion Tool in an impact-minimizing tray. Packaged two (2) individual sterile trays per box, the Comfortear™ individual sterile trays reduce the potential for unnecessary waste when only a single occulder is required. Pedi, 0.5mm.
MICROSPECIALITIES, INC.
24-2004
In Commercial Distribution

  • 30810003223587 ()
  • 10810003223583 ()

  • Outer Diameter: 0.5 Millimeter
24-2004

  • Lacrimal punctum plug
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