restor3d Lumbar Instrumentation

GUDID 00840097509969

ALIF Disc Prep - Lid

Restor3d, Inc.

Instrument tray, reusable

• Primary Device ID: 00840097509969
• NIH Device Record Key: 8127f3cb-502c-4d3a-94bf-cd6808a1eedf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Lumbar Instrumentation
• Version Model Number: 5113-B0002
• Company DUNS: 080819836
• Company Name: Restor3d, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097509969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234087

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

[00840097509969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [restor3d Lumbar Instrumentation]

• 00840097509990: ALIF Disc Prep - Level 3
• 00840097509983: ALIF Disc Prep - Level 2
• 00840097509976: ALIF Disc Prep - Level 1
• 00840097509969: ALIF Disc Prep - Lid
• 00840097509952: ALIF Disc Prep - Case
• 00840097509730: Large Cobb Angled 28mm
• 00840097509723: Small Cobb Angled 22mm
• 00840097509716: Large Cobb Straight 28mm
• 00840097509709: Small Cobb Straight 22mm
• 00840097509693: Osteotome Angled 15mm
• 00840097509686: Osteotome Straight 15mm
• 00840097509679: Nerve Root Probe
• 00840097509662: Nerve Hook
• 00840097509655: Push Curette (Elephant foot)
• 00840097509648: Ring Curette Stirrup Up
• 00840097509631: Ring Curette Stirrup Straight
• 00840097509624: Cup 5 Curette Up
• 00840097509617: Cup 2 Curette Up
• 00840097509600: Cup 5 Curette Straight
• 00840097509594: Cup 2 Curette Straight
• 00840097509587: Rasp Angled Double Sided
• 00840097509570: Rasp Straight Double Sided
• 00840097509563: Bone Rongeur 8mm Double Action
• 00840097509556: Kerrison Rongeur Straight 6mm, 13"
• 00840097509549: Kerrison Rongeur Straight 4mm, 13"
• 00840097509532: Kerrison Rongeur Straight 2mm, 13"
• 00840097505305: Pituitary Rongeur Straight 6mm, 13"
• 00840097505299: Pituitary Rongeur Straight 4mm, 13"
• 00840097505282: Scalpel Handle Long 15"