Straumann XenoFlex

Primary DI
08809186541787
Brand
Straumann XenoFlex
Company
Nibec Co., Ltd.
Model
NI-0110-050
Device description
Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Straumann Xenograft®) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
Published
2017-10-26
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
K142040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142040000OCS-B COLLAGENNibec Co., Ltd.2015-07-31NPM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186541787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186541787088091865417878809186541787

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
+827050068814dasue3635@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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