restor3d OsseoREBAR Nail

GUDID 00840097504643

Ti-6Al-4V Nail, 2.0 x 70mm, Trocar Tip

Restor3d

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00840097504643
• NIH Device Record Key: a8487b63-0954-4bac-ba6b-629951432fe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d OsseoREBAR Nail
• Version Model Number: 1140-0270TR
• Company DUNS: 080819836
• Company Name: Restor3d
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097504643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211789

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [restor3d OsseoREBAR Nail]

• 00840097504667: Ti-6Al-4V Nail, 4.0 x 70mm, Trocar Tip
• 00840097504650: Ti-6Al-4V Nail, 3.0 x 70mm, Trocar Tip
• 00840097504643: Ti-6Al-4V Nail, 2.0 x 70mm, Trocar Tip