Home GUDID 04719873029891 Bicera® Resorbable Bone Substitute
Primary DI 04719873029891
Brand Bicera® Resorbable Bone Substitute
Company Wiltrom Co., Ltd. (Chutung)
Model BC-G04(2.0-3.0mm,7c.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
Product Codes# Code, Name table Code Name MQV Filler, Bone Void, Calcium Compound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQV Filler, Bone Void, Calcium Compound Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719873029891 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719873029891 04719873029891 4719873029891
GMDN Terms# Term, Definition table Term Definition Synthetic bone graft An 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 Type Low High Condition Storage Environment Temperature 23 Degrees Celsius 27 Degrees Celsius
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 DI Brand Model Catalog Published 04719873027606 Bicera® Resorbable Bone Substitute BC-B01(5x5x20mm,2c.c.) 2020-12-29 04719873027613 Bicera® Resorbable Bone Substitute BC-B02(5x5x10mm,2c.c.) 2019-09-10 04719873027620 Bicera® Resorbable Bone Substitute BC-B03(5x5x10mm,5c.c.) 2019-09-10 04719873027637 Bicera® Resorbable Bone Substitute BC-B04(5x5x10mm,7c.c.) 2019-09-10 04719873027644 Bicera® Resorbable Bone Substitute BC-B05(5x5x10mm,10c.c.) 2019-09-10 04719873027651 Bicera® Resorbable Bone Substitute BC-B06(5x5x20mm,5c.c.) 2019-09-10 04719873027668 Bicera® Resorbable Bone Substitute BC-B07(5x5x20mm,7c.c.) 2019-09-10 04719873027675 Bicera® Resorbable Bone Substitute BC-B08 (5x5x20mm,10c.c.) 2019-09-10 04719873027682 Bicera® Resorbable Bone Substitute BC-B09 (5x5x20mm,20c.c.) 2019-09-10 04719873027699 Bicera® Resorbable Bone Substitute BC-B10 (5x5x20mm,30c.c.) 2019-09-10 04719873027705 Bicera® Resorbable Bone Substitute BC-B11 (5x5x10mm,20c.c.) 2019-09-10 04719873027712 Bicera® Resorbable Bone Substitute BC-B12 (5x5x10mm,30c.c.) 2019-09-10 04719873029877 Bicera® Resorbable Bone Substitute BC-G02(1.0-2.0mm,5c.c.) 2019-09-10 04719873029884 Bicera® Resorbable Bone Substitute BC-G03(0.5-1.0mm,5c.c.) 2019-09-10 04719873029907 Bicera® Resorbable Bone Substitute BC-G05(2.0-3.0mm,10c.c.) 2019-09-10 04719873029914 Bicera® Resorbable Bone Substitute BC-G06(1.0-2.0mm,7c.c.) 2019-09-10 04719873029921 Bicera® Resorbable Bone Substitute BC-G07(1.0-2.0mm,10c.c.) 2019-09-10 04719873029938 Bicera® Resorbable Bone Substitute BC-G08(0.5-1.0mm,7c.c.) 2019-09-10 04719873029945 Bicera® Resorbable Bone Substitute BC-G09(0.5-1.0mm,10c.c.) 2019-09-10 04719873029969 Bicera® Resorbable Bone Substitute BC-G11(0.25-0.5mm,0.5g) 2019-09-10
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