FDA.reportPublic FDA data

Tutopatch™ bovine pericardium 10x16 cm

Primary DI
04041543311907
Brand
Tutopatch™ bovine pericardium 10x16 cm
Company
Tutogen Medical GmbH
Model
BP1016
Catalog number
BP1016
Device description
Bovine Pericardium 10 x 16cm
Published
2015-12-14
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
DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
FTMMesh, surgical
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
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2
FTMMesh, SurgicalGeneral, 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081538000
K991296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081538000TUTOPATCH, TUTOMESHRti Biologics, Inc.2008-06-19FTM
K991296000TUTOPATCHTutogen Medical U.S., Inc.2000-10-06FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041543311907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041543311907040415433119074041543311907

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbableA 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]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde) and may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343337499
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041543305463COPIOS® Pericardium Membranexz0112777762015-12-14
04041543305470COPIOS® Pericardium Membranexz0123777772015-12-14
04041543305487COPIOS® Pericardium Membranexz0134777782015-12-14
04041543311846Tutopatch™ bovine pericardium 6x8 cmBP0608BP06082015-12-14
04041543311853Tutopatch™ bovine pericardium 8x11 cmBP0811BP08112015-12-14
04041543311860Tutopatch™ bovine pericardium 8x14 cmBP0814BP08142015-12-14
04041543311877Tutopatch™ bovine pericardium 8x16 cmBP0816BP08162015-12-14
04041543311884Tutopatch™ bovine pericardium 8x18 cmBP0818BP08182015-12-14
04041543311891Tutopatch™ bovine pericardium10x12.5 cmBP1013BP10132015-12-14
04041543311914Tutopatch™ bovine pericardium 12x12 cmBP1212BP12122015-12-14
04041543311921Tutopatch™ bovine pericardium 12x16 cmBP1216BP12162015-12-14
04041543311945Tutopatch™ bovine pericardium 14x20 cmBP1420BP14202015-12-14
04041543311952Tutomesh™ bovine pericardium10x16 cmBP3016BP30162015-12-14
04041543311969Tutomesh™ bovine pericardium 13x22 cmBP3322BP33222015-12-14
04041543311976Tutopatch™ bovine pericardium 6x18 cmBP0618BP06182015-12-14
04041543311983Fortiva™ Porcine DermisPD0606PD06062015-10-24
04041543311990Fortiva™ Porcine DermisPD0808PD08082015-10-24
04041543312003Fortiva™ Porcine DermisPD0822PD08222015-10-24
04041543312010Fortiva™ Porcine DermisPD1010PD10102015-10-24
04041543312027Fortiva™ Porcine DermisPD1016PD10162015-10-24

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