OsOpia

Primary DI
08720165038077
Brand
OsOpia
Company
RevisiOs B.V.
Model
702-021-US
Device description
OsOpia Granules 0.5cc 0.25-1mm
Published
2021-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
08720165038077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720165038077087201650380778720165038077

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, compositeA sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Contacts#

Phone, Email table
PhoneEmail
+31302297280marcel.borger@kurosbio.com

Regulatory Flags#

DUNS number
489274404
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
false
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
08720165038084OsOpia702-022-US2021-07-01
08720165038091OsOpia702-023-US2021-06-30
08720165038107OsOpia702-024-US2021-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640164360065Gibson Healthcare AlloplastDegradable Solutions AGLYC2024-03-05
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