PURcore 012-PUR

GUDID 00812593020361

PURcore, 12cc

BIOGENNIX LLC

Synthetic bone graft

• Primary Device ID: 00812593020361
• NIH Device Record Key: 3116325b-9450-45cb-83ac-4f1362e4ab0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURcore
• Version Model Number: 012-PUR
• Catalog Number: 012-PUR
• Company DUNS: 021486533
• Company Name: BIOGENNIX LLC
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812593020361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142828

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: 2019-07-17
• Device Publish Date: 2019-07-09

On-Brand Devices [PURcore]

• 00812593020361: PURcore, 12cc
• 00812593020354: PURcore, 6cc
• 00812593020347: PURcore, 3cc