FDA.reportPublic FDA data

Meso Tendon Matrix

Primary DI
00812337020800
Brand
Meso Tendon Matrix
Company
DSM BIOMEDICAL, INC.
Model
30054-02
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812337020800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337020800008123370208008123370208000812337020800

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Centimeter
Width5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020794Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020817Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020824Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
05694310966443Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966474Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966467Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966450Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
00860011716730B3 GEL SystemTybr Health, Inc.OWY2025-12-17
00888867395084Arthrex®ARTHREX, INC.OWY2025-12-01
00888867395091Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543133Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543140Arthrex®ARTHREX, INC.OWY2025-12-01
00810063820534Tapestry Biointegrative ImplantEmbody, Inc.OWY2025-04-21
00810063820541Tapestry Biointegrative ImplantEmbody, Inc.OWY2025-04-21
10653405990123BioBraceConmed CorporationOWY2024-09-20
10653405990130BioBraceConmed CorporationOWY2024-09-20
10653405990147BioBraceConmed CorporationOWY2024-09-20
10653405990154BioBraceConmed CorporationOWY2024-09-20
20653405990120BioBraceConmed CorporationOWY2024-09-20
20653405990137BioBraceConmed CorporationOWY2024-09-20
20653405990151BioBraceConmed CorporationOWY2024-09-20
10653405988946BioBraceConmed CorporationOWY2024-02-12
10653405988939BioBraceConmed CorporationOWY2024-02-12
10653405988953BioBraceConmed CorporationOWY2024-02-12
10653405988960BioBraceConmed CorporationOWY2024-02-12
00810063820473TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09
00810063820480TAPESTRY Biointegrative Implant with Introducer, w/ CannulaEmbody, Inc.OWY2024-02-09
00810063820510TAPESTRY RC Biointegrative Implant SystemEmbody, Inc.OWY2024-02-09