DynaLevin Waterproof Adhesive Bordered Foam Dressing

Primary DI
00616784302119
Brand
DynaLevin Waterproof Adhesive Bordered Foam Dressing
Company
Dynarex Corporation
Model
3021
Device description
"DynaLevin Waterproof Adhesive Bordered Foam Dressing, 4""x4"""
Published
2021-06-21
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
NADDressing, Wound, Occlusive

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784302126PackageGS110In Commercial Distribution
00616784302133PackageGS112In Commercial Distribution
00616784302119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784302126006167843021266167843021260616784302126
00616784302133006167843021336167843021330616784302133
00616784302119006167843021196167843021190616784302119

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
No natural rubber latex
true

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