EIT PLIF Disc space opener

GUDID 04260557776117

Collapsed Disc Space Opener

EIT Emerging Implant Technologies GmbH

Orthopaedic surgical distractor, internal

• Primary Device ID: 04260557776117
• NIH Device Record Key: e620d0af-14ac-4181-a919-749081c61f80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Disc space opener
• Version Model Number: PET10051
• 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	04260557776117 [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

[04260557776117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-13

On-Brand Devices [EIT PLIF Disc space opener]

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