AccuFill ® PreFill 206150

GUDID 00889024501232

Etex Corporation

Synthetic bone graft

• Primary Device ID: 00889024501232
• NIH Device Record Key: 3ef2c6ce-be27-4cb8-bd19-95bfdb1bcda7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuFill ® PreFill
• Version Model Number: 206150
• Catalog Number: 206150
• Company DUNS: 622221141
• Company Name: Etex Corporation
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024501232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182107

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: 2019-12-26
• Device Publish Date: 2019-12-18

On-Brand Devices [AccuFill ® PreFill]

• 00889024501232: 206150
• 00889024501225: 206130