ComfortGauze Border

Primary DI
00714196052636
Brand
ComfortGauze Border
Company
DERMARITE INDUSTRIES 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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883925562
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00714196464507AquaRite Ag Extra CMC464502025-06-01
00714196052629ComfortGauze Border422622025-01-08
01714196930711Bordered Foam Healogics by DermaRite930712020-09-01
01714196930735Bordered Foam Healogics by DermaRite930732020-09-01

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