Bicera® Resorbable Bone Substitute

Primary DI
04719875720130
Brand
Bicera® Resorbable Bone Substitute
Company
Wiltrom Co., Ltd. (Chutung)
Model
BC-G28(2.0-3.0mm,20c.c.)
Device description
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60%hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Published
2019-09-10
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
04719875720130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875720130047198757201304719875720130

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 Temperature23 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88636107168yichun@wiltrom.com.tw

Regulatory Flags#

DUNS number
658742740
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873027606Bicera® Resorbable Bone SubstituteBC-B01(5x5x20mm,2c.c.)2020-12-29
04719873027613Bicera® Resorbable Bone SubstituteBC-B02(5x5x10mm,2c.c.)2019-09-10
04719873027620Bicera® Resorbable Bone SubstituteBC-B03(5x5x10mm,5c.c.)2019-09-10
04719873027637Bicera® Resorbable Bone SubstituteBC-B04(5x5x10mm,7c.c.)2019-09-10
04719873027644Bicera® Resorbable Bone SubstituteBC-B05(5x5x10mm,10c.c.)2019-09-10
04719873027651Bicera® Resorbable Bone SubstituteBC-B06(5x5x20mm,5c.c.)2019-09-10
04719873027668Bicera® Resorbable Bone SubstituteBC-B07(5x5x20mm,7c.c.)2019-09-10
04719873027675Bicera® Resorbable Bone SubstituteBC-B08 (5x5x20mm,10c.c.)2019-09-10
04719873027682Bicera® Resorbable Bone SubstituteBC-B09 (5x5x20mm,20c.c.)2019-09-10
04719873027699Bicera® Resorbable Bone SubstituteBC-B10 (5x5x20mm,30c.c.)2019-09-10
04719873027705Bicera® Resorbable Bone SubstituteBC-B11 (5x5x10mm,20c.c.)2019-09-10
04719873027712Bicera® Resorbable Bone SubstituteBC-B12 (5x5x10mm,30c.c.)2019-09-10
04719873029877Bicera® Resorbable Bone SubstituteBC-G02(1.0-2.0mm,5c.c.)2019-09-10
04719873029884Bicera® Resorbable Bone SubstituteBC-G03(0.5-1.0mm,5c.c.)2019-09-10
04719873029891Bicera® Resorbable Bone SubstituteBC-G04(2.0-3.0mm,7c.c.)2019-09-10
04719873029907Bicera® Resorbable Bone SubstituteBC-G05(2.0-3.0mm,10c.c.)2019-09-10
04719873029914Bicera® Resorbable Bone SubstituteBC-G06(1.0-2.0mm,7c.c.)2019-09-10
04719873029921Bicera® Resorbable Bone SubstituteBC-G07(1.0-2.0mm,10c.c.)2019-09-10
04719873029938Bicera® Resorbable Bone SubstituteBC-G08(0.5-1.0mm,7c.c.)2019-09-10
04719873029945Bicera® Resorbable Bone SubstituteBC-G09(0.5-1.0mm,10c.c.)2019-09-10

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