FDA.reportPublic FDA data

PermeaDerm®

Primary DI
10810125742245
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117174392
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
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10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
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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
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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