SiOxD Wound Matrix EDS-10058

GUDID 10850021883000

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.

Sioxmed, LLC

Synthetic wound matrix dressing
Primary Device ID10850021883000
NIH Device Record Keye5ba29c8-c6ac-4ffe-a966-3cb157f52632
Commercial Distribution StatusIn Commercial Distribution
Brand NameSiOxD Wound Matrix
Version Model NumberEDS-10058
Catalog NumberEDS-10058
Company DUNS035978729
Company NameSioxmed, LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com
Phone3365512209
Emailsupport@sioxmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850021883003 [Unit of Use]
GS110850021883000 [Primary]

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-25
Device Publish Date2025-02-17

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