EIT ALIF Implant Guide

GUDID 04260557774816

Trial and Implant Guide, large

EIT Emerging Implant Technologies GmbH

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• Primary Device ID: 04260557774816
• NIH Device Record Key: 486c704c-a999-4b1e-8f5b-22cb17ed3eb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT ALIF Implant Guide
• Version Model Number: AET30121
• Company DUNS: 313088331
• Company Name: EIT Emerging Implant Technologies GmbH
• 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: true
• 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	04260557774816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170503

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

[04260557774816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-11
• Device Publish Date: 2018-01-09

On-Brand Devices [EIT ALIF Implant Guide]

• 04260557774816: Trial and Implant Guide, large
• 04260557774809: Trial and Implant Guide, small