EIT PLIF Inserter

GUDID 04260397088388

T-Handle Inserter

EIT Emerging Implant Technologies GmbH

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 04260397088388
• NIH Device Record Key: 0f960bf6-2cee-495b-b0f1-09f88a7a1bfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Inserter
• Version Model Number: PET30101
• 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	04260397088388 [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

[04260397088388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-01-05

On-Brand Devices [EIT PLIF Inserter]

• 04260397088388: T-Handle Inserter
• 04260397088067: Inserter Pin SH Connection
• 04260397088050: Inserter S-Hammer Connection
• 04260397080832: Inserter