FDA.report

CuraFoam Foam Dressing

Primary DI
00616784301327
Brand
CuraFoam Foam Dressing
Company
DYNAREX CORPORATION
Model
3013
Device description
CuraFoam Foam Dressing 6"x6"
Published
2021-06-21
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

Related Records

Product Codes

CodeName
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784301327PackageGS110In Commercial Distribution
00616784301334PackageGS112In Commercial Distribution
00616784301310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784301327006167843013276167843013270616784301327
00616784301334006167843013346167843013340616784301334
00616784301310006167843013106167843013100616784301310

GMDN Terms

TermDefinition
Negative-pressure wound therapy system foam dressing, 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), and that contains an antimicrobial agent [e.g., silver (Ag)]. 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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