FDA.reportPublic FDA data

PermeaDerm®

Primary DI
00810125740114
Brand
PermeaDerm®
Company
Stedical Scientific, Inc.
Model
PDC 2.5x5
Catalog number
C1250500
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.
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153678000PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc.2016-08-08FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810125740111PackageGS110In Commercial Distribution
20810125740118PackageGS14In Commercial Distribution
00810125740114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012574011110810125740111
2081012574011820810125740118
00810125740114008101257401148101257401140810125740114

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA 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.

Contacts#

Phone, Email table
PhoneEmail
(858) 753-9530customerservice@stedical.com

Regulatory Flags#

DUNS number
117174392
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810125740107PermeaDerm®PDC 2.5 x 2.5C32525002026-03-03
00810125740176PermeaDerm®PDC 5x5C20505002026-03-03
00810125740213PermeaDerm®PDG XXLG6XXL0002026-03-03
00810125741043PermeaDerm®PDB 5x10B10510002026-03-03
00810125741074PermeaDerm®PDB 10x15B21015002026-03-03
00810125741104PermeaDerm®PDB 15x30B41530002026-03-03
00810125742217PermeaDerm®PDG XSG1XS00002026-03-03
00810125742224PermeaDerm®PDG SMG2S000002026-03-03
00810125742231PermeaDerm®PDG MEDG3M000002026-03-03
00810125742248PermeaDerm®PDG LGG4L000002026-03-03
00810125742255PermeaDerm®PDG XLG5XL00002026-03-03
10810125740104PermeaDerm®PDC 2.5 x 2.5C32525002026-03-03
10810125740111PermeaDerm®PDC 2.5x5C12505002026-03-03
10810125740173PermeaDerm®PDC 5x5C20505002026-03-03
10810125740210PermeaDerm®PDG XXLG6XXL0002026-03-03
10810125741040PermeaDerm®PDB 5x10B10510002026-03-03
10810125741071PermeaDerm®PDB 10x15B21015002026-03-03
10810125741101PermeaDerm®PDB 15x30B41530002026-03-03
10810125742214PermeaDerm®PDG XSG1XS00002026-03-03
10810125742221PermeaDerm®PDG SMG2S000002026-03-03

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Primary DI, Brand, Company table
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00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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