PermeaDerm®

Basic Information

• Brand Name: PermeaDerm®
• Primary DI: 00810125742613
• Version / Model: PDB 5x10
• Company Name: Stedical Scientific, Inc.
• Labeler DUNS: 117174392
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 4
• Public Version Date: 2026-02-11
• Public Version Status: Update
• Public Device Record Key: b2ecc02b-64bf-489f-ac45-73fcc92562f8
• Distribution End Date: 2025-06-04

Device Description

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.

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: No
• 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	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810125742610	GS1	Case	4	Not in Commercial Distribution	2025-06-04
Primary	00810125742613	GS1
Unit of Use	20810125742617	GS1

Premarket Submissions

Submission Number	Supplement Number
K153678	000