FDA.reportPublic FDA data

"Duma+ Collagen Wound Dressing, 4"" x 4"" "

Primary DI
00840117343351
Brand
"Duma+ Collagen Wound Dressing, 4"" x 4"" "
Company
Dynarex Corporation
Model
3097
Device description
Sterile-R
Published
2025-06-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117343276PackageGS110In Commercial Distribution
00840117343313PackageGS110In Commercial Distribution
00840117343351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117343276008401173432768401173432760840117343276
00840117343313008401173433138401173433130840117343313
00840117343351008401173433518401173433510840117343351

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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