FDA.reportPublic FDA data

Actifuse Shape

Primary DI
05060050780647
Brand
Actifuse Shape
Company
Apatech Ltd
Model
506005078064
Catalog number
506005078064
Device description
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 2.6ml 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
05060050780647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060050780647050600507806475060050780647

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 Volume2.6Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature40 Degrees Fahrenheit90 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
05060050780289Actifuse Granules5060050780285060050780282015-09-24
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
05060050780661Actifuse Shape5060050780665060050780662015-09-24
05060050780685Actifuse Shape5060050780685060050780682015-09-24
05060050780708Actifuse MIS5060050780705060050780702015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27