Bi-Portal Bone Graft Delivery Device 10101-S

GUDID 00863462000205

Bone Graft Delivery Device

SPINAL SURGICAL STRATEGIES

Bone grafting cannula

• Primary Device ID: 00863462000205
• NIH Device Record Key: 7321e8fc-1844-491d-a425-92b8507a9725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bi-Portal Bone Graft Delivery Device
• Version Model Number: 10101-S
• Catalog Number: 10101-S
• Company DUNS: 016181482
• Company Name: SPINAL SURGICAL STRATEGIES
• 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: 6507204766
• Email: h.kirschner@spinalsurgicalstrategies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863462000205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142661

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[00863462000205]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-12-20