FDA.reportPublic FDA data

TissueMend®

Primary DI
10381780545774
Brand
TissueMend®
Company
INTEGRA LIFESCIENCES
Model
6495-9-007
Catalog number
6495-9-007
Device description
TissueMend® Soft Tissue Repair Matrix, 2cm x 15cm (0.5mm - 1.54mm)
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K060989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060989000TISSUEMEND SOFT TISSUE REPAIR MATRIXTei Biosciences, Inc.2006-05-15FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780545774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178054577410381780545774

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Do not use if package is damaged or open.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
016419552
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780545781TissueMend®6495-9-0036495-9-0032026-11-02
10381780545316PriMatrix®607-005-018607-005-0182026-01-12
10381780545323PriMatrix®607-005-220607-005-2202026-01-12
10381780545330PriMatrix®607-005-330607-005-3302026-01-12
10381780545347PriMatrix®607-005-440607-005-4402026-01-12
10381780545354PriMatrix®607-005-550607-005-5502026-01-12
10381780545361PriMatrix®607-005-660607-005-6602026-01-12
10381780545378PriMatrix®607-005-880607-005-8802026-01-12
10381780545385PriMatrix®607-005-812607-005-8122026-01-12
10381780545392PriMatrix®607-001-112607-001-1122026-01-12
10381780545408PriMatrix®607-005-125607-005-1252026-01-12
10381780545415PriMatrix®607-005-225607-005-2252026-01-12
10381780545576PriMatrix®607-001-440607-001-4402026-01-12
10381780545583PriMatrix®607-004-440607-004-4402026-01-12
10381780545590PriMatrix®607-001-660607-001-6602026-01-12
10381780545606PriMatrix®607-004-660607-004-6602026-01-12
10381780545613PriMatrix®607-001-880607-001-8802026-01-12
10381780545620PriMatrix®607-004-880607-004-8802026-01-12
10381780545637PriMatrix®607-001-812607-001-8122026-01-12
10381780545644PriMatrix®607-001-125607-001-1252026-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780545781TissueMend®INTEGRA LIFESCIENCESFTM2026-11-02
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00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
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09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTM2025-11-26
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09421906017670Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-04-01
09421906017663Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDFTM2022-03-23
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