FDA.reportPublic FDA data

ComfortGauze Border

Primary DI
01714196422636
Brand
ComfortGauze Border
Company
Sion Brands LLC
Model
42263
Device description
DermaRite’s ComfortGauze™ Border offers the simple and reliable protection and absorption of bordered gauze, with the addition of a gentle, silicone, adhesive layer that makes dressing removal safer and more comfortable for compromised or at-risk skin.
Published
2025-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714196052636PackageGS125In Commercial Distribution
01714196422636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714196052636007141960526367141960526360714196052636
01714196422636017141964226361714196422636

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Regulatory Flags#

DUNS number
118753405
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196003317DermaCol 100 Gel 1oz Tube0033112026-06-01
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz Tube111052026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz Tube111072026-06-01
01714196112452DermaRite Medical Wound Gel- Amorphous Hydrogel112452026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4222042026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4333042026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz Tube20301US2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz Tube20501US2026-06-01
00714196112453DermaSyn112452020-09-01
00714196930712Bordered Foam Healogics by DermaRite930712020-09-01
00714196930736Bordered Foam Healogics by DermaRite930732020-09-01
01714196422629ComfortGauze Border422622025-01-08
07141964645074AquaRite Ag Extra CMC464502025-06-01
07141964666000AquaRite Ag Extra CMC466602025-06-01
71419624712486DermaSyn002472024-10-21
01714196500150SilvaKollagen Gel00500005002023-10-04
00714196390028AquaDerm00322E2022-05-02
00714196391780DermaFilm thin with Border00229E2021-09-10
00714196390004Adhesive Tape Remover Pads821002021-09-09
00714196390042AquaDerm00324E2021-09-09

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