DEVICE: Foundation® (04560245656821)

Device Identifier (DI) Information

Foundation®
27-500-100
In Commercial Distribution
27-500-100
OLYMPUS TERUMO BIOMATERIALS CORP.
04560245656821
GS1

1
697730638 *Terms of Use
Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of absorbable atelo-collagen. The atelo-collagen has been cross-linked by heat treatment in order to achieve biocompatibility. FOUNDATION is provided in bullet shapes. The collagen (liquid form) suspension is pored into a bullet shape mold. The design of the bullet shape is to permit easy placement into the extraction socket. It consists of fibrillar and heat-denatured atelo-collagen. Fibrillar atelo-collagen provides scaffolding for surrounding cells and the heat-denatured atelo-collagen stimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental bone matrix implant, animal-derived A 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.
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FDA Product Code

[?]
Product Code Product Code Name
LYC Bone Grafting Material, Synthetic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111087 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 30 Degrees Celsius
Storage Environment Temperature: less than 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Length: 25 Millimeter
Outer Diameter: 8 Millimeter
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Device Record Status

8cea1c11-bca4-4d82-947e-4a1e85892574
July 06, 2018
3
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14560245656828 10 04560245656821 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-831-3222
info@jmoritausa.com
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