EIT ALIF Trial

GUDID 04260397089965

Trial, H 8mm, 0°, L

EIT Emerging Implant Technologies GmbH

Spinal implant trial

• Primary Device ID: 04260397089965
• NIH Device Record Key: 11bc1ca1-a378-4166-9593-cb55bb3481ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT ALIF Trial
• Version Model Number: AET00840
• 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	04260397089965 [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

[04260397089965]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-09-19

On-Brand Devices [EIT ALIF Trial]

• 04260557774670: Trial, H 19mm, 20°, XL
• 04260557774663: Trial, H 18mm, 20°, XL
• 04260557774656: Trial, H 17mm, 20°, XL
• 04260557774649: Trial, H 16mm, 20°, XL
• 04260557774632: Trial, H 15mm, 20°, XL
• 04260557774625: Trial, H 14mm, 20°, XL
• 04260557774618: Trial, H 13mm, 20°, XL
• 04260557774601: Trial, H 20mm, 15°, XL
• 04260557774595: Trial, H 19mm, 15°, XL
• 04260557774588: Trial, H 18mm, 15°, XL
• 04260557774571: Trial, H 17mm, 15°, XL
• 04260557774564: Trial, H 16mm, 15°, XL
• 04260557774557: Trial, H 15mm, 15°, XL
• 04260557774540: Trial, H 14mm, 15°, XL
• 04260557774533: Trial, H 13mm, 15°, XL
• 04260557774526: Trial, H 12mm, 15°, XL
• 04260557774519: Trial, H 11mm, 15°, XL
• 04260557774502: Trial, H 20mm, 10°, XL
• 04260557774496: Trial, H 19mm, 10°, XL
• 04260557774489: Trial, H 18mm, 10°, XL
• 04260557774472: Trial, H 17mm, 10°, XL
• 04260557774465: Trial, H 16mm, 10°, XL
• 04260557774458: Trial, H 15mm, 10°, XL
• 04260557774441: Trial, H 14mm, 10°, XL
• 04260557774434: Trial, H 13mm, 10°, XL
• 04260557774427: Trial, H 12mm, 10°, XL
• 04260557774410: Trial, H 11mm, 10°, XL
• 04260557774403: Trial, H 10mm, 10°, XL
• 04260557774397: Trial, H 20mm, 5°, XL
• 04260557774380: Trial, H 19mm, 5°, XL
• 04260557774373: Trial, H 18mm, 5°, XL
• 04260557774366: Trial, H 17mm, 5°, XL
• 04260557774359: Trial, H 16mm, 5°, XL
• 04260557774342: Trial, H 15mm, 5°, XL
• 04260557774335: Trial, H 14mm, 5°, XL
• 04260557774328: Trial, H 13mm, 5°, XL
• 04260557774311: Trial, H 12mm, 5°, XL
• 04260557774304: Trial, H 11mm, 5°, XL
• 04260557774298: Trial, H 10mm, 5°, XL
• 04260557774281: Trial, H 9mm, 5°, XL
• 04260557774274: Trial, H 8mm, 5°, XL
• 04260557774267: Trial, H 20mm, 0°, XL
• 04260557774250: Trial, H 19mm, 0°, XL
• 04260557774243: Trial, H 18mm, 0°, XL
• 04260557774236: Trial, H 17mm, 0°, XL
• 04260557774229: Trial, H 16mm, 0°, XL
• 04260557774212: Trial, H 15mm, 0°, XL
• 04260557774205: Trial, H 14mm, 0°, XL
• 04260557774199: Trial, H 13mm, 0°, XL
• 04260557774182: Trial, H 12mm, 0°, XL