FDA.reportPublic FDA data

ReproBone

Primary DI
05060171623311
Brand
ReproBone
Company
CERAMISYS LTD
Model
RBD2
Device description
ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.0cc
Published
2015-07-31
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

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103820000REPROBONE DENTAL GRAFTING MATERIALCeramisys, Ltd.2011-11-03LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060171623311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060171623311050601716233115060171623311

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
423459374
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060171621850Orbital Implant InserterINSTR012015-07-31
05060171621867Hydroxyapatite Orbital ImplantSP142015-07-31
05060171621874Hydroxyapatite Orbital ImplantSP162015-07-31
05060171621881Hydroxyapatite Orbital ImplantSP182015-07-31
05060171621898Hydroxyapatite Orbital ImplantSP202015-07-31
05060171621904Hydroxyapatite Orbital ImplantSP222015-07-31
05060171621911Alumina Orbital ImplantSA142015-07-31
05060171621928Alumina Orbital ImplantSA162015-07-31
05060171621935Alumina Orbital ImplantSA182015-07-31
05060171621942Alumina Orbital ImplantSA202015-07-31
05060171621959Alumina Orbital ImplantSA222015-07-31
05060171621966Orbtex Orbital ImplantRPX162015-07-31
05060171621973Orbtex Orbital ImplantRPX182015-07-31
05060171621980Orbtex Orbital ImplantRPX202015-07-31
05060171621997Orbtex Orbital ImplantRPX222015-07-31
05060171623281ReproBoneRBD0252015-07-31
05060171623298ReproBoneRBD052015-07-31
05060171623304ReproBoneRBD12015-07-31
05060171623328ReproBoneRBD2.52015-07-31
05060171623335ReproBoneRBD32015-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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