FDA.reportPublic FDA data

COPIOS® Pericardium Membrane

Primary DI
04041543305470
Brand
COPIOS® Pericardium Membrane
Company
Tutogen Medical GmbH
Model
xz0123
Catalog number
77777
Device description
COPIOS® Pericardium Membrane is a natural collagenous membrane for use in periodontal and/or dental surgical procedures.
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
NPLBarrier, animal source, intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073097000TUTODENT DENTAL MEMBRANETutogen Medical U.S., Inc.2008-05-12NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041543305470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041543305470040415433054704041543305470

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
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
04041543311907Tutopatch™ bovine pericardium 10x16 cmBP1016BP10162015-12-14
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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