FDA.reportPublic FDA data

GENOSS Collagen Membrane

Primary DI
08809324764030
Brand
GENOSS Collagen Membrane
Company
GENOSS CO., Ltd.
Model
GCT2420
Catalog number
GCT2420
Device description
Resorbable Dental Barrier membrane
Published
2016-03-09
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
K102307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102307000GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELSGenoss Co., Ltd.2011-05-04NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809324764030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809324764030088093247640308809324764030

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width24Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
690083006
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026544722Implant Guide Kit GIGK2024-07-19
08800026544739Implant Guide Kit GGD26292024-07-19
08800026544746Implant Guide Kit GGD26352024-07-19
08800026544753Implant Guide Kit GMG22024-07-19
08800026544760Implant Guide Kit GSP052024-07-19
08800026544777Implant Guide Kit GSP072024-07-19
08800026544784Implant Guide Kit GSP092024-07-19
08800026544791Implant Guide Kit GSP112024-07-19
08800026544807Implant Guide Kit GGP04052024-07-19
08800026544814Implant Guide Kit GGP06072024-07-19
08800026544821Implant Guide Kit GGP08092024-07-19
08800026544838Implant Guide Kit GGP10112024-07-19
08800026501558GENOSS Inflator B30GBI-B302024-06-18
08800026501565GENOSS Inflator B30GBI-302024-06-18
08800026507598GENOSS Inflator B30GBI-B30S2024-06-18
08800026507611GENOSS Inflator B40 GBI-B40V2024-06-18
08800026507635GENOSS Inflator B40 GBI-B40VS2024-06-18
08800026512752GENOSS Inflator B40 GBI-B40S2024-06-18
08800026530329GENOSS Inflator B30GBI-B302024-06-18
08809324765433GENOSS Inflator B30GBI-30V2024-06-18

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