FDA.reportPublic FDA data

Meso Tendon Matrix

Primary DI
00812337020817
Brand
Meso Tendon Matrix
Company
DSM BIOMEDICAL, INC.
Model
30054-03
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
00812337020817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337020817008123370208178123370208170812337020817

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
Length6Centimeter
Width8Centimeter

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
M263W25000WizardBio Resorbable Calcium Phosphate Cement21004-05W250002019-01-02
00812337020442Drillable Bone Void Filler21005-0307.705.003S2023-01-11
00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
M26300110301005CopiOs® Bone Void Filler Sponge20101-0200-1103-010-052015-09-17
M26300110301010CopiOs® Bone Void Filler Sponge20101-0300-1103-010-102015-09-17
M26300110302001CopiOs® Bone Void Filler Paste20102-0100-1103-020-012015-09-17
M26300110302005CopiOs® Bone Void Filler Paste20102-0200-1103-020-052015-09-17
M26300110302010CopiOs® Bone Void Filler Paste20102-0300-1103-020-102015-09-17
M2630011301001CopiOs® Bone Void Filler Sponge20101-0100-1103-010-012015-09-17
M2630700582001CopiOs® Bone Void Filler Sponge20100-0107.00582.0012015-09-17
M2630700582003CopiOs® Bone Void Filler Sponge20100-0207.00582.0032015-09-17
M2630700582004CopiOs® Bone Void Filler Sponge20100-0307.00582.0042015-09-17
00812337020435BoneSync Fast-Setting Drillable Calcium Phosphate Cement, 1cc21003-04ABS-31012023-05-09
M263300700402DSM Biomedical Dental Bone Graft30070-042021-10-20
M263300700503DSM Biomedical Dental Bone Graft30070-052021-10-20
M263300700604DSM Biomedical Dental Bone Graft30070-062021-10-20
M263300700705DSM Biomedical Dental Bone Graft30070-072021-10-20
M263300700806DSM Biomedical Dental Bone Graft30070-082021-10-20
M263300700907DSM Biomedical Dental Bone Graft30070-092021-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20845854655501Argo KnotlessConmed CorporationOWY2026-09-25
20845854655518Argo KnotlessConmed CorporationOWY2026-09-25
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020794Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020800Meso 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