sioxmed.comSBC1 Cream
Sioxmed, LLC
SiOxMed, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3025431504 | 3025431504 | SiOxMed, LLC | 1 | N | 2026-01-01 | 2452 Salem Park Dr Winston Salem NC US 27127 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850021883003 | SiOxD Wound Matrix - 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. | 3365512209 | support@sioxmed.com |
| 00850021883027 | SiOxC - SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist skin environment. SiOxC Cream is provided prescription only in various sizes for single patient use. Indications for use: SiOxC Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores. Specifically, SiOxC Cream contains milled amorphous silica fibers that are highly absorbent, retain moisture, and promote a moist environment. These fibers are not absorbed into the skin. As desired, any residual fibers may be removed from the skin after the cream is absorbed. SiOxC Cream is provided prescription only in various sizes for single patient use | 3365512209 | support@sioxmed.com |
| 00850021883034 | SiOxC - SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist skin environment. SiOxC Cream is provided prescription only in various sizes for single patient use. Indications for use: SiOxC Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores. Specifically, SiOxC Cream contains milled amorphous silica fibers that are highly absorbent, retain moisture, and promote a moist environment. These fibers are not absorbed into the skin. As desired, any residual fibers may be removed from the skin after the cream is absorbed. SiOxC Cream is provided prescription only in various sizes for single patient use | 3365512209 | support@sioxmed.com |
| 00850021883041 | SiOxD Wound Matrix - 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. | 3365512209 | support@sioxmed.com |
| 00850021883058 | SiOxC - SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient. | 3365512209 | support@sioxmed.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 312260 | 1919717704 | K250890 | SBC1 Cream | FRO | 2026-01-12 |
| 312260 | 1206368770 | K242406 | SiOxC Cream | FRO | 2025-03-13 |
| 312260 | 1479468801 | K241660 | SiOxD® Wound Matrix | QSZ | 2024-07-05 |
Product Codes Associated With Registrations#
PMN#
SiOxC Cream
Sioxmed, LLC
SiOxD® Wound Matrix
Sioxmed, LLC
SiOxD Wound Matrix
Sioxmed, LLC
SiOxD Hemostatic Wound Matrix
SiOxMed, LLC.
GUDID#
SiOxD® OR - 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.
2026-03-17
SiOxC - SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient.
2026-01-21
SiOxC - SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient.
2026-01-21
SiOxC - SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist skin environment. SiOxC Cream is provided prescription only in various sizes for single patient use. Indications for use: SiOxC Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores. Specifically, SiOxC Cream contains milled amorphous silica fibers that are highly absorbent, retain moisture, and promote a moist environment. These fibers are not absorbed into the skin. As desired, any residual fibers may be removed from the skin after the cream is absorbed. SiOxC Cream is provided prescription only in various sizes for single patient use
2025-11-10
SiOxC - SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist skin environment. SiOxC Cream is provided prescription only in various sizes for single patient use. Indications for use: SiOxC Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on Breached or Compromised skin or open sores. Specifically, SiOxC Cream contains milled amorphous silica fibers that are highly absorbent, retain moisture, and promote a moist environment. These fibers are not absorbed into the skin. As desired, any residual fibers may be removed from the skin after the cream is absorbed. SiOxC Cream is provided prescription only in various sizes for single patient use
2025-11-10
SiOxD Wound Matrix - 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.
2025-11-10
SiOxD Wound Matrix - 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.
2025-11-10
SiOxD Wound Matrix - 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.
2025-02-17