Foundation®

Primary DI
04560245656814
Brand
Foundation®
Company
OLYMPUS TERUMO BIOMATERIALS CORP.
Model
27-500-200
Catalog number
27-500-200
Device description
Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560245656811PackageGS15Not in Commercial Distribution
04560245656814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456024565681114560245656811
04560245656814045602456568144560245656814

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
800-831-3222info@jmoritausa.com

Regulatory Flags#

DUNS number
697730638
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560245656821Foundation®27-500-10027-500-1002015-09-24
14560245656811Foundation®27-500-20027-500-2002015-09-24
14560245656828Foundation®27-500-10027-500-1002015-09-24

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