FDA.reportPublic FDA data

MatriDerm pluS+ Bi-Layer

Primary DI
04250569302435
Brand
MatriDerm pluS+ Bi-Layer
Company
MedSkin Solutions Dr. Suwelack AG
Model
83534-300
Catalog number
83534-300
Published
2026-05-18
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

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250864000MatriDerm pluS+ Bi-LayerMedskin Solutions Dr. Suwelack AG2025-12-19KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250569302435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250569302435042505693024354250569302435

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2Millimeter
Length297Millimeter
Width210Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
318479870
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250569301780MatriDerm83405-30083405-3002021-10-15
04250569301735MatriDerm83404-30083404-3002021-10-15
04250569301742MatriDerm83403-30083403-3002021-10-16
04250569301759MatriDerm83401-30083401-3002021-10-15
04250569301766MatriDerm83500-30083500-3002021-10-15
04250569301773MatriDerm83400-30083400-3002021-10-15
04250569302428MatriDerm pluS+ Bi-Layer83533-30083533-3002026-05-18
04250569302442MatriDerm pluS+ Bi-Layer83535-30083535-3002026-05-18
04250569302459MatriDerm pluS+ Bi-Layer83536-30083536-3002026-05-18
04250569302466MatriDerm pluS+ Bi-Layer83538-30083538-3002026-05-18
04250569302473MatriDerm pluS+ Bi-Layer83539-30083539-3002026-05-18
04250569302480MatriDerm pluS+ Bi-Layer83540-30083540-3002026-05-18
04250569302497MatriDerm pluS+ Bi-Layer83541-300 83541-300 2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632656OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632670OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632687OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632700OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632755OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02