Synthecure 20-112

GUDID 00862835000408

Calcium Sulfate Bone Void Filler, Small

AUSTIN MEDICAL VENTURES INC.

Bone matrix implant, synthetic

• Primary Device ID: 00862835000408
• NIH Device Record Key: 3e242d34-3169-46b0-b04e-0230c3512c1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthecure
• Version Model Number: 20-112
• Catalog Number: 20-112
• Company DUNS: 014795494
• Company Name: AUSTIN MEDICAL VENTURES INC.
• 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: false
• 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

Customer Support Contacts

• Phone: 901-748-2581
• Email: info@synthecure.com

Device Dimensions

• Weight: 12 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862835000408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031838

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2017-07-10

On-Brand Devices [Synthecure]

• 00862835000415: Calcium Sulfate Bone Void Filler, Medium
• 00862835000408: Calcium Sulfate Bone Void Filler, Small
• 00862835000422: Calcium Sulfate Bone Void Filler, Large
• 00862835000453: Bone Void Filler Kit, 20cc
• 00862835000446: Bone Void Filler Kit, 5cc
• 00862835000439: Bone Void Filler Kit, 10cc
• 00862835000477: Bone Void Filler Kit, 3cc