FDA.reportPublic FDA data

COPIOS® Pericardium Membrane

Primary DI
04041543305487
Brand
COPIOS® Pericardium Membrane
Company
Tutogen Medical GmbH
Model
xz0134
Catalog number
77778
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
04041543305487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041543305487040415433054874041543305487

GMDN Terms#

Term, Definition table
TermDefinition
Dental soft-tissue matrix implant, animal-derivedA bioabsorbable animal-derived collagen (e.g., porcine) intended to be used to aid in the regeneration of oral soft tissue, lost due to periodontal disease or trauma, through promotion of new blood vessels and/or by providing a temporary scaffold for tissue ingrowth; it is indicated for various oral soft tissue augmentation procedures (e.g., alveolar ridge reconstruction, localized gingival augmentation, covering of recession defects and extraction sockets). It is a pliable material which may be fixed to soft tissues with sutures; it is applied to soft tissue during periodontal flap surgery and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.

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
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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