PermeaDerm®

Basic Information

• Brand Name: PermeaDerm®
• Primary DI: 00810125740008
• Version / Model: PDC 5x5
• Catalog Number: C2050500
• Company Name: Stedical Scientific, Inc.
• Labeler DUNS: 117174392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-05
• Public Version: 3
• Public Version Date: 2026-02-11
• Public Version Status: Update
• Public Device Record Key: f86a7837-c197-4ade-aeb4-1f9e1720ffd7

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
Primary	00810125740008	GS1
Package	10810125740005	GS1	Inner Pack	10	In Commercial Distribution
Package	20810125740002	GS1	Case	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153678	000