FDA.reportPublic FDA data

geneX® ds

Primary DI
15060155710959
Brand
geneX® ds
Company
BIOCOMPOSITES LTD
Model
980-002
Catalog number
980-002
Device description
geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. One component of the matrix prevents soft tissue in-growth until it is resorbed and replaced by new bony tissue. Another component has been shown to act as a scaffold through which new bone grows. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe.When injected the mixture sets to form geneX®; a hard but resorbable matrix.
Published
2020-01-07
Public version status
New
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
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50601557109526PreviousGS10
15060155710959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5060155710952650601557109526
1506015571095915060155710959

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit113 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+441782338580info@biocomposites.com

Regulatory Flags#

DUNS number
424382307
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060155712205Synicem Knee Spacer Trial Tray with Trials8820248820242025-07-08
15060155712328Synicem 58 Knee Trial FDA8854188854182025-07-08
15060155712342Synicem 65 Knee Trial FDA8854198854192025-07-08
15060155712366Synicem 72 Knee Trial FDA8854208854202025-07-08
15060155712380Synicem 79 Knee Trial FDA8854218854212025-07-08
15060155712700Synicem Knee Spacer Trial Case (marked)5150905150902025-07-08
15060155712021Synicem Hip Spacer 40C8854308854302025-07-08
15060155712038Synicem Hip Spacer 48C8854318854312025-07-08
15060155712045Synicem Hip Spacer 56C8854328854322025-07-08
15060155712052Synicem Hip Spacer 40CXL8854338854332025-07-08
15060155712069Synicem Hip Spacer 48CXL8854348854342025-07-08
15060155712076Synicem Hip Spacer 56CXL8854358854352025-07-08
15060155712083Synicem Hip Spacer 48M8854368854362025-07-08
15060155712090Synicem Hip Spacer 56M8854378854372025-07-08
15060155712106Synicem Hip Spacer Trial Tray Regular with Trials8820228820222025-07-08
15060155712113Synicem Hip Spacer Trial Tray XL with Trials8820238820232025-07-08
15060155712120Synicem Knee Spacer R588854388854382025-07-08
15060155712137Synicem Knee Spacer L588854398854392025-07-08
15060155712144Synicem Knee Spacer R658854408854402025-07-08
15060155712151Synicem Knee Spacer L658854418854412025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08