FDA.reportPublic FDA data

Actifuse Granules

Primary DI
05060050780289
Brand
Actifuse Granules
Company
Apatech Ltd
Model
506005078028
Catalog number
506005078028
Device description
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 5ml pack size
Published
2015-09-24
Public version status
Update
Distribution status
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
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060050780289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060050780289050600507802895060050780289

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, syntheticA sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
221517829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05413760467450Ostene150383115038312015-09-24
05413760467467Ostene150383215038322015-09-24
05413760467474Ostene150383315038332015-09-24
05060050780296Actifuse Granules5060050780295060050780292015-09-24
05060050780302Actifuse Granules5060050780305060050780302015-09-24
05060050780449Actifuse Microgranules5060050780445060050780442015-09-24
05060050780456Actifuse Microgranules5060050780455060050780452015-09-24
05060050780463Actifuse Microgranules5060050780465060050780462015-09-24
05060050780500Actifuse ABX5060050780505060050780502015-09-24
05060050780517Actifuse ABX5060050780515060050780512015-09-24
05060050780524Actifuse ABX5060050780525060050780522015-09-24
05060050780548Actifuse E-Z-Prep5060050780545060050780542015-09-24
05060050780562Actifuse Granules5060050780565060050780562015-09-24
05060050780586Actifuse ABX5060050780585060050780582015-09-24
05060050780609Actifuse ABX5060050780605060050780602015-09-24
05060050780623Actifuse Shape5060050780625060050780622015-09-24
05060050780647Actifuse Shape5060050780645060050780642015-09-24
05060050780661Actifuse Shape5060050780665060050780662015-09-24
05060050780685Actifuse Shape5060050780685060050780682015-09-24
05060050780708Actifuse MIS5060050780705060050780702015-09-24

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Primary DI, Brand, Company table
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00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9000301001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000305001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000310001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000405001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000410001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000430001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000510001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000530001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000630001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9380000057CERASORB Bioactivecurasan AGLYC2026-06-25
ECUR9380000058CERASORB Bioactivecurasan AGLYC2026-06-25
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURH20V1000Osbone Dentalcurasan AGLYC2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24