Bio2 Technologies

GUDID B01010000421

VITRIUM E 20 x 6

BIO2 TECHNOLOGIES, INC.

Synthetic bone graft

• Primary Device ID: B01010000421
• NIH Device Record Key: f9356e7a-d1c4-43b1-80f8-a1b843b43a08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio2 Technologies
• Version Model Number: 1000042
• Company DUNS: 832629898
• Company Name: BIO2 TECHNOLOGIES, 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: 9999999999
• Email: productinfo@bio2tech.com
• Phone: 9999999999
• Email: productinfo@bio2tech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01010000421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142463

FDA Product Code

• OIS: Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-01

On-Brand Devices [Bio2 Technologies]

• B0101000259: Vitrium E Instruments
• B0101000258: Vitrium C Instruments
• B01010002321: VITRIUM C LARGE, 8 x 23
• B01010002311: VITRIUM C MEDIUM, 8 x 23
• B01010001321: Vitrium PIP Standard Straight
• B01010001301: Vitrium PIP Standard Angled
• B01010001291: Vitrium PIP Small Straight
• B01010000721: VITRIUM C SMALL, 7 x 20
• B01010000711: VITRIUM C SMALL, 6 x 20
• B01010000701: VITRIUM C SMALL, 5 x 20
• B01010000691: VITRIUM C SMALL, 4 x 20
• B01010000681: VITRIUM C SMALL, 7 x 16
• B01010000671: VITRIUM C SMALL, 6 x 16
• B01010000661: VITRIUM C SMALL, 5 x 16
• B01010000651: VITRIUM C SMALL, 4 x 16
• B01010000641: VITRIUM C LARGE, 7 x 23
• B01010000631: VITRIUM C LARGE, 6 x 23
• B01010000621: VITRIUM C MEDIUM, 7 x 23
• B01010000611: VITRIUM C MEDIUM, 6 x 23
• B01010000601: VITRIUM C MEDIUM, 7 x 20
• B01010000591: VITRIUM C MEDIUM, 6 x 20
• B01010000581: VITRIUM C MEDIUM, 5 x 20
• B01010000571: VITRIUM C MEDIUM, 4 x 20
• B01010000561: VITRIUM C MEDIUM, 7 x 16
• B01010000551: VITRIUM C MEDIUM, 6 x 16
• B01010000541: VITRIUM C MEDIUM, 5 x 16
• B01010000531: VITRIUM C MEDIUM, 4 x 16
• B01010000521: VITRIUM E 22 x 10
• B01010000511: VITRIUM E 22 x 9
• B01010000501: VITRIUM E 22 x 8
• B01010000491: VITRIUM E 22 x 7
• B01010000481: VITRIUM E 22 x 6
• B01010000471: VITRIUM E 22 x 5
• B01010000461: VITRIUM E 20 x 10
• B01010000451: VITRIUM E 20 x 9
• B01010000441: VITRIUM E 20 x 8
• B01010000431: VITRIUM E 20 x 7
• B01010000421: VITRIUM E 20 x 6
• B01010000411: VITRIUM E 20 x 5
• B01010000401: VITRIUM E 18 x 10
• B01010000391: VITRIUM E 18 x 9
• B01010000381: VITRIUM E 18 x 8
• B01010000371: VITRIUM E 18 x 7
• B01010000361: VITRIUM E 18 x 6
• B01010000351: VITRIUM E 18 x 5