FDA.reportPublic FDA data

Meso Wound Matrix

Primary DI
M26330052130
Brand
Meso Wound Matrix
Company
DSM BIOMEDICAL, INC.
Model
30052-13
Published
2015-09-15
Public version status
Update
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
KGNDressing, Wound, Collagen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112888000MESO WOUND MATRIXKensey Nash Corporation2012-02-10KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M26330052130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Centimeter
Width6Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
484-713-2100ClinReg.ExtonPA@dsm.com

Regulatory Flags#

DUNS number
131107757
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812337020039XCM Biologic® Tissue Matrix 30010-03XM106.0204S2015-09-17
00812337020046XCM Biologic® Tissue Matrix 30010-04XM106.0307S2015-09-17
00812337020060XCM Biologic® Tissue Matrix30010-06XM106.0407S2015-09-17
00812337020084XCM Biologic® Tissue Matrix 30010-08XM106.0416S2015-09-17
00812337020091XCM Biologic® Tissue Matrix30010-09XM106.0420S2015-09-17
00812337020114XCM Biologic® Tissue Matrix30010-11XM106.0516S2015-09-17
00812337020138XCM Biologic® Tissue Matrix30010-13XM106.0612S2015-09-17
00812337020145XCM Biologic® Tissue Matrix30010-14XM106.0616S2015-09-17
00812337020152XCM Biologic® Tissue Matrix30010-15XM106.0620S2015-09-17
00812337020190XCM Biologic® Tissue Matrix 30010-19XM106.0812S2015-09-17
00812337020206XCM Biologic® Tissue Matrix30010-20XM106.0816S2015-09-17
00812337020213XCM Biologic® Tissue Matrix30010-21XM106.0820S2015-09-17
00812337020220XCM Biologic® Tissue Matrix30010-22XM106.1016S2015-09-17
00812337020237XCM Biologic® Tissue Matrix30010-23XM106.1020S2015-09-17
00812337020251XCM Biologic® Tissue Matrix30010-25XM106.1220S2015-09-17
00812337020268XCM Biologic® Tissue Matrix 30010-26XM106.1620S2015-09-17
00812337020299XCM Biologic® Tissue Matrix30010-29XM106.1625S2015-09-17
00812337020305XCM Biologic® Tissue Matrix30010-30XM106.2020S2015-09-17
00812337020312XCM Biologic® Tissue Matrix30010-31XM106.2025S2015-09-17
00812337020329XCM Biologic® Tissue Matrix30010-32XM106.2030S2015-09-17

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Primary DI, Brand, Company table
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00850084084041CURCOFR TECH, LLCKGN2026-06-02
00850084084058CURCOFR TECH, LLCKGN2026-06-02
00850084084065CURCOFR TECH, LLCKGN2026-06-02
00850084084072CURCOFR TECH, LLCKGN2026-06-02
00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
07610221017737Derma-Gide®Geistlich Pharma AGKGN2026-06-01
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31
16942327004853DimoraWinner Medical Co., Ltd.KGN2026-03-30