FDA.reportPublic FDA data

Medeor Tendon Matrix

Primary DI
00812337020695
Brand
Medeor Tendon Matrix
Company
DSM BIOMEDICAL, INC.
Model
30006-01
Device description
Medeor Tendon Matrix 5cm x 5cm
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
FTMMesh, Surgical
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXEMesh, Surgical, Collagen, Staple Line Reinforcement
OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2
OXBMesh, Surgical, Collagen, Thoracic, Chest Wall ReconstructionGeneral, Plastic Surgery2
OXEMesh, Surgical, Collagen, Staple Line ReinforcementGeneral, Plastic Surgery2
OXHMesh, Surgical, Collagen, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2
PAJMesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812337020695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812337020695008123370206958123370206950812337020695

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
Length5Centimeter
Width5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00temperature sensitive, do not exceed 35 degrees C, do not use if temperature indicator is red
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
484-713-2100clinreg.extonpa@dsm-firmenich.com

Regulatory Flags#

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

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00812337020459Drillable Bone Void Filler21005-0507.705.005S2023-01-11
00812337020466Drillable Bone Void Filler21005-1007.705.010S2023-01-11
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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

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