FDA.reportPublic FDA data

TenoMend

Primary DI
00813954020709
Brand
TenoMend
Company
COLLAGEN MATRIX, INC.
Model
CTW12025
Device description
Collagen Tendon Wrap
Published
2015-10-23
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

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080452000COLLAGEN TENDON WRAPCollagen Matrix, Inc.2008-05-15FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813954020709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954020709008139540207098139540207090813954020709

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176262442
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954022857ABIL PuttyA0506-012019-05-07
00813954022864ABIL PuttyA0506-022019-05-07
00813954022871ABIL PuttyA0506-032019-05-07
00813954022888ABIL Conformable PuttyA0507-012019-05-07
00813954022895ABIL Conformable PuttyA0507-022019-05-07
05060440334139NeoGen Collagen Flex640502019-06-24
00813954023915OssiMend Bioactive MoldableMCCBA05032020-09-15
00813954022901OssiMend Bioactive MoldableMCCBA0252019-08-22
00813954022918OssiMend Bioactive MoldableMCCBA052019-08-22
00813954022925OssiMend Bioactive MoldableMCCBA05062019-08-22
00813954022932OssiMend Bioactive MoldableMCCBA10062019-08-22
00813954022949OssiMend Bioactive MoldableMCCBA10122019-08-22
00813954022956OssiMend Bioactive MoldableMCCBA20122019-08-22
00813954022963OssiMend Bioactive MoldableMCCBA20252019-08-22
00813954022970OssiMend Bioactive MoldableMCCBA40252019-08-22
05060440334146NeoGen Collagen Flex640512019-06-24
05060440334153NeoGen Collagen Flex640522019-06-24
05060440334160NeoGen Collagen Firm640552019-06-24
05060440334177NeoGen Collagen Firm640562019-06-24
05060440334184NeoGen Collagen Firm640572019-06-24

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00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
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09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTM2025-11-26
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