FDA.reportPublic FDA data

DynaFoam Waterproof Bordered Foam Dressing

Primary DI
00616784303826
Brand
DynaFoam Waterproof Bordered Foam Dressing
Company
DYNAREX CORPORATION
Model
3038
Device description
DynaFoam Waterproof Bordered Foam Dressing, 6"x6", Composite
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

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784303826PackageGS110In Commercial Distribution
00616784303833PackageGS112In Commercial Distribution
00616784303819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784303826006167843038266167843038260616784303826
00616784303833006167843038336167843038330616784303833
00616784303819006167843038196167843038190616784303819

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.

Sterilization Methods#

Method table
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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00616784703411"IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)"70342016-09-24
00616784703718"IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)"70372016-09-24
00616784704814"IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) "70482016-09-24
00616784704913"IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)"70492016-09-24
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