FDA.reportPublic FDA data

PermeaDerm®

Primary DI
10810125740104
Brand
PermeaDerm®
Company
Stedical Scientific, Inc.
Model
PDC 2.5 x 2.5
Catalog number
C3252500
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
10810125740104PackageGS110In Commercial Distribution
20810125740101PackageGS14In Commercial Distribution
00810125740107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012574010410810125740104
2081012574010120810125740101
00810125740107008101257401078101257401070810125740107

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
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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