EIT PLIF Disc space opener

GUDID 04260397080887

Disc space opener

EIT Emerging Implant Technologies GmbH

Orthopaedic surgical distractor, internal

• Primary Device ID: 04260397080887
• NIH Device Record Key: d3455638-fd1c-46ad-b45c-dad6330a9a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Disc space opener
• Version Model Number: PET10050
• 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	04260397080887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170503

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04260397080887]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-09

On-Brand Devices [EIT PLIF Disc space opener]

• 04260557776117: Collapsed Disc Space Opener
• 04260397080887: Disc space opener