si_Mochi VET1201-O

GUDID 05060548020125

Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use

BIOSTONE CO. LIMITED

Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID05060548020125
NIH Device Record Keyadc93c7e-20b8-47fc-b395-ecc77ef112ef
Commercial Distribution StatusIn Commercial Distribution
Brand Namesi_Mochi
Version Model NumberVET1201-O
Catalog NumberVET1201-O
Company DUNS222236587
Company NameBIOSTONE CO. LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060548020125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

On-Brand Devices [si_Mochi]

05060548020095Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020101Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020088Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020033Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020026Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020019Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020002Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020200Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020194Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020163Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020156Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020149Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020132Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
05060548020125Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
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