FDA UDI In Commercial Distribution 🇺🇸 United States

SiOxD® OR

DI: 00850021883072 · Model: SiOxD® OR Wound Matrix, 1g · Sioxmed, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SiOxD® OR
Primary DI
00850021883072
Version / Model
SiOxD® OR Wound Matrix, 1g
Catalog Number
EDS-10050
Company Name
Sioxmed, LLC
Labeler DUNS
035978729
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-03-17
Public Version
1
Public Version Date
2026-03-25
Public Version Status
New
Public Device Record Key
d31670ca-742e-4816-bc2f-80e32148f16a

Device Description

The SiOxD® OR Wound Matrix is a non-pyrogenic, sterile, single use device intended for use in local management of wounds. The SiOxD® OR Wound Matrix is a soft, white, conformable, non-woven, absorbent, biocompatible fiber matrix made from synthetic biomaterials. The SiOxD® OR Wound Matrix conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The SiOxD® OR 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® OR Wound Matrix promotes a moist environment for the body’s natural healing process. Indications for Use: The SiOxD® OR Wound Matrix is intended for use in the management of wounds. Wound types include Partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first degree and partial thickness burns, skin tears) and draining wounds.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
QSZ Absorbable Synthetic Wound Dressing

GMDN Terms

Code Name
64853 Synthetic wound matrix dressing

Identifiers

Type ID
Primary 00850021883072

Customer Contacts

Phone
3365512209