FDA.reportPublic FDA data

SiOxD Wound Matrix

Primary DI
10850021883000
Brand
SiOxD Wound Matrix
Company
Sioxmed, LLC
Model
EDS-10058
Catalog number
EDS-10058
Device description
The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD Wound Matrix is structurally similar to collagen, a key component of the native extracellular matrix, and serves as a scaffold for cellular infiltration and vascularization. SiOxD Wound Matrix promotes a moist environment for the body’s natural healing process.
Published
2025-02-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSZAbsorbable Synthetic Wound DressingUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850021883000PrimaryGS10
00850021883003Unit of UseGS10
00850021883133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002188300010850021883000
00850021883003008500218830038500218830030850021883003
00850021883133008500218831338500218831330850021883133

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3365512209support@sioxmed.com

Regulatory Flags#

DUNS number
035978729
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021883072SiOxD® ORSiOxD® OR Wound Matrix, 1gEDS-100502026-03-17
00850021883058SiOxCSBC1, 1 Oz, 1 UnitEDS-140012026-01-21
00850021883065SiOxCSBC1, 8 Oz, 1 UnitEDS-140022026-01-21
00850021883027SiOxCSiOxC Cream 1 Oz 1 UnitEDS-110162025-11-10
00850021883034SiOxCSiOxC Cream 8 Oz 1 UnitEDS-110192025-11-10
00850021883003SiOxD Wound MatrixSiOxD 0.3g 2.5in Round (0.35in) 1 Unit MylarEDS-100622025-11-10
00850021883041SiOxD Wound MatrixUniversal Combat Matrix (UCM) 0.7g 2.5in Round (0.EDS-130012025-11-10

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