SynthaGen HaTCP MIS-1205-FO

GUDID 05060548020330

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 foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.

BIOSTONE CO. LIMITED

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 05060548020330
• NIH Device Record Key: 09ebfe2d-17f3-448e-9ce4-a803ef02eeb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynthaGen HaTCP
• Version Model Number: MIS-1205-FO
• Catalog Number: MIS-1205-FO
• 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: false
• 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	05060548020330 [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: 2024-08-27
• Device Publish Date: 2024-08-19

On-Brand Devices [SynthaGen HaTCP]

• 05060548020347: Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
• 05060548020330: Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm
• 05060548020293: Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm