PermeaDerm® G1XS0000

GUDID 10810125742214

PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness wounds, surgical wounds, trauma wounds, donor sites, and the coverage of meshed autografts.

Stedical Scientific, Inc.

Animal-derived wound matrix dressing

• Primary Device ID: 10810125742214
• NIH Device Record Key: 10f4462b-f1c9-4fc9-a05d-2d93a69370ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PermeaDerm®
• Version Model Number: PDG XS
• Catalog Number: G1XS0000
• Company DUNS: 117174392
• Company Name: Stedical Scientific, Inc.
• 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: false
• Single Use: true
• 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: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com
• Phone: (858) 753-9530
• Email: customerservice@stedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810125742217 [Primary]
GS1	10810125742214 [Package]; Contains: 00810125742217; Package: Carton [2 Units]; In Commercial Distribution
GS1	20810125742211 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153678

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-11
• Device Publish Date: 2026-03-03

On-Brand Devices [PermeaDerm®]

• 10810125742252: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125742245: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125742238: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125742221: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125742214: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125741101: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125741071: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125741040: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125740210: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125740173: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125740111: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness
• 10810125740104: PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness