si_Mochi VET1205-M

GUDID 05060548020194

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

BIOSTONE CO. LIMITED

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 05060548020194
• NIH Device Record Key: fbb2306a-602e-478d-b507-096c3d5a8b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: si_Mochi
• Version Model Number: VET1205-M
• Catalog Number: VET1205-M
• Company DUNS: 222236587
• Company Name: BIOSTONE CO. LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060548020194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202639

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [si_Mochi]

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