SiOxC EDS-14002

GUDID 00850021883065

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.

Sioxmed, LLC

Dry skin moisture barrier dressing

• Primary Device ID: 00850021883065
• NIH Device Record Key: b6198dae-85ec-4dc8-a14d-df0396ef6248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SiOxC
• Version Model Number: SBC1, 8 Oz, 1 Unit
• Catalog Number: EDS-14002
• Company DUNS: 035978729
• Company Name: Sioxmed, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com
• Phone: 3365512209
• Email: support@sioxmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021883065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250890

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-29
• Device Publish Date: 2026-01-21

On-Brand Devices [SiOxC]

• 00850021883034: SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for
• 00850021883027: SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for
• 00850021883065: SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a mo
• 00850021883058: SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a mo