FDA.reportPublic FDA data

PermeaDerm®

Primary DI
00810125742248
Brand
PermeaDerm®
Company
Stedical Scientific, Inc.
Model
PDG LG
Catalog number
G4L00000
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
10810125742245PackageGS12In Commercial Distribution
20810125742242PackageGS14In Commercial Distribution
00810125742248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012574224510810125742245
2081012574224220810125742242
00810125742248008101257422488101257422480810125742248

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
00810125740114PermeaDerm®PDC 2.5x5C12505002026-03-03
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22