EIT PLIF Handle

GUDID 04260397080856

T-handle

EIT Emerging Implant Technologies GmbH

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 04260397080856
• NIH Device Record Key: 4b232694-50ec-498e-9e4c-cce5322b598b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Handle
• Version Model Number: PET00910
• 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	04260397080856 [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

[04260397080856]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-01-05

On-Brand Devices [EIT PLIF Handle]

• 04260397088098: T-handle long
• 04260397080863: Straight handle
• 04260397080856: T-handle