creos xenogain

Primary DI
08809186540643
Brand
creos xenogain
Company
Nibec Co., Ltd.
Model
N1121
Device description
Creos xenogain is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The creos xenogain contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of creos xenogain is effective for the regeneration of new bone around the grafted bone. The creos xenogain has good osteoconductivity to enhance new bone formation.
Published
2016-09-23
Public version status
Update
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
NPMBone Grafting Material, Animal Source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPMBone Grafting Material, Animal SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113246000OCS-BNibec Company, Limited2013-01-16NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186540643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186540643088091865406438809186540643

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone void filling material, animal-derivedA bioabsorbable, implantable device made primarily of animal-derived materials (e.g., bovine, porcine) intended to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill bone cavities and defects. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+827050068814webmaster@nibec.co.kr

Regulatory Flags#

DUNS number
687796909
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08809186541299Equimatrix08-30502026-10-06
08809186540926Equimatrix06-00252026-09-29
08809186540933Equimatrix06-00502026-09-29
08809186540940Equimatrix06-01002026-09-29
08809186540957Equimatrix06-02002026-09-29
08809186540964Equimatrix06-10252026-09-29
08809186540971Equimatrix06-10502026-09-29
08809186540988Equimatrix06-11002026-09-29
08809186540995Equimatrix06-12002026-09-29
08809186541305Equimatrix06-40252026-09-29
08809186541312Equimatrix06-40502026-09-29
08809186541329Equimatrix06-60252026-09-29
08809186541336Equimatrix06-60502026-09-29
08809186540179OCS-B1-0210-0252016-09-22
08809186540186OCS-B1-0210-0502016-09-22
08809186540193OCS-B1-0210-1002016-09-22
08809186540209OCS-B1-0210-2002016-09-22
08809186540223OCS-B1-1020-0252016-09-22
08809186540230OCS-B1-1020-0502016-09-22
08809186540247OCS-B1-1020-1002016-09-22

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