EIT TLIF Impactor

GUDID 04260397087657

Large Impactor

EIT Emerging Implant Technologies GmbH

Orthopaedic implant impactor

• Primary Device ID: 04260397087657
• NIH Device Record Key: 7952871b-69d7-4c94-9623-a35574ae0525
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT TLIF Impactor
• Version Model Number: TET30201
• 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	04260397087657 [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

[04260397087657]

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: 2018-01-05

On-Brand Devices [EIT TLIF Impactor]

• 04260397087657: Large Impactor
• 04260397081440: Impactor