DEVICE: Foundation® (04560245656814)
Device Identifier (DI) Information
Foundation®
27-500-200
In Commercial Distribution
27-500-200
OLYMPUS TERUMO BIOMATERIALS CORP.
27-500-200
In Commercial Distribution
27-500-200
OLYMPUS TERUMO BIOMATERIALS CORP.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47968 | 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYC | Bone Grafting Material, Synthetic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 30 Degrees Celsius |
Storage Environment Temperature: less than 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 25 Millimeter |
Outer Diameter: 15 Millimeter |
Device Record Status
4641e9fe-031b-4447-84be-4827cbb022b6
September 07, 2023
4
September 24, 2015
September 07, 2023
4
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14560245656811 | 5 | 04560245656814 | 2026-02-28 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-831-3222
info@jmoritausa.com
info@jmoritausa.com