FDA.reportPublic FDA data

si_Mochi

Primary DI
05060548020194
Brand
si_Mochi
Company
BIOSTONE CO. LIMITED
Model
VET1205-M
Catalog number
VET1205-M
Device description
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both the foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch. Then packed in a carton box. Animal use only
Published
2023-05-01
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

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202639000si-MochiBiostone, Ltd.2021-04-21MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060548020194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548020194050605480201945060548020194

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
222236587
Device count
1
HCT/P
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060548020620InteliGraft™IG-SBG01IG-SBG012025-12-10
05060548020637InteliGraft™IG-SBG02IG-SBG022025-12-10
05060548020644InteliGraft™IG-SBG03IG-SBG032025-12-10
05060548020651InteliGraft™IG-SBG05IG-SBG052025-12-10
05060548020668InteliGraft™IG-SBG10IG-SBG102025-12-10
05060548020675InteliGraft™IG-MIS-SBG05IG-MIS-SBG052025-12-10
05060548020682InteliGraft™IG-MIS-SBG10IG-MIS-SBG102025-12-10
05060548020354BioViveSBG1DE-OBS-011DE-OBS-012024-12-02
05060548020361BioViveSBG1DE-OBS-021DE-OBS-022024-12-02
05060548020378BioViveSBG1DE-OBS-031DE-OBS-032024-12-02
05060548020385BioViveSBG1DE-OBS-051DE-OBS-052024-12-02
05060548020392BioViveSBG1DE-OBS-101DE-OBS-102024-12-02
05060548020408BioViveSBG1DE-MIS-051DE-MIS-052024-12-02
05060548020415BioViveSBG1DE-MIS-101DE-MIS-102024-12-02
05060548020293SynthaGen HaTCPOBS-1202-FOOBS-1202-FO2024-08-19
05060548020330SynthaGen HaTCPMIS-1205-FOMIS-1205-FO2024-08-19
05060548020347SynthaGen HaTCPMIS-1210-FOMIS-1210-FO2024-08-19
05060548020217OsteoXcell BAOSBA-001OSBA-0012024-07-18
05060548020224OsteoXcell BAOSBA-002OSBA-0022024-07-18
05060548020231OsteoXcell BA OSBA-003OSBA-0032024-07-18

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