EIT PLIF Trial

GUDID 04260397084045

Trial, H: 13 mm, 12°, 30/9

EIT Emerging Implant Technologies GmbH

Spinal implant trial

• Primary Device ID: 04260397084045
• NIH Device Record Key: f6f511a2-642a-4c95-899e-ed97dce927e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EIT PLIF Trial
• Version Model Number: PET31310
• 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	04260397084045 [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

[04260397084045]

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: 2018-09-21

On-Brand Devices [EIT PLIF Trial]

• 04260614036581: Trial, H: 16 mm, 18°, 30/6
• 04260557836330: Trial, H: 16 mm, 0°, 30/11
• 04260557836323: Trial, H: 15 mm, 0°, 30/11
• 04260557836316: Trial, H: 14 mm, 0°, 30/11
• 04260557836309: Trial, H: 13 mm, 0°, 30/11
• 04260557836293: Trial, H: 12 mm, 0°, 30/11
• 04260557836286: Trial, H: 11 mm, 0°, 30/11
• 04260557836279: Trial, H: 10 mm, 0°, 30/11
• 04260557836262: Trial, H: 9 mm, 0°, 30/11
• 04260557836255: Trial, H: 8 mm, 0°, 30/11
• 04260557836248: Trial, H: 7 mm, 0°, 30/11
• 04260557836231: Trial, H: 16 mm, 0°, 30/9
• 04260557836224: Trial, H: 15 mm, 0°, 30/9
• 04260557836217: Trial, H: 14 mm, 0°, 30/9
• 04260557836200: Trial, H: 13 mm, 0°, 30/9
• 04260557836194: Trial, H: 12 mm, 0°, 30/9
• 04260557836187: Trial, H: 11 mm, 0°, 30/9
• 04260557836170: Trial, H: 10 mm, 0°, 30/9
• 04260557836156: Trial, H: 8 mm, 0°, 30/9
• 04260557836149: Trial, H: 7 mm, 0°, 30/9
• 04260397088371: Trial, H 15mm, 18°, 30/6
• 04260397088364: Trial, H: 14 mm, 18°, 30/6
• 04260397088357: Trial, H 13mm, 18°, 30/6
• 04260397088340: Trial, H: 12 mm, 18°, 30/6
• 04260397088333: Trial, H 11mm, 18°, 30/6
• 04260397088326: Trial, H: 10 mm, 18°, 30/6
• 04260397088319: Trial, H: 16 mm, 12°, 30/6
• 04260397088302: Trial, H 15mm, 12°, 30/6
• 04260397088296: Trial, H: 14 mm, 12°, 30/6
• 04260397088289: Trial, H 13mm, 12°, 30/6
• 04260397088272: Trial, H: 12 mm, 12°, 30/6
• 04260397088265: Trial, H 11mm, 12°, 30/6
• 04260397088258: Trial, H: 10 mm, 12°, 30/6
• 04260397088241: Trial, H: 9 mm, 12°, 30/6
• 04260397087725: Trial, H: 16 mm, 12°, 30/9
• 04260397087718: Trial, H: 16 mm, 8°, 30/11
• 04260397087695: Trial, H: 16 mm, 6°, 30/11
• 04260397087688: Trial, H: 16 mm, 6°, 30/9
• 04260397087671: Trial, H: 16 mm, 4°, 30/11
• 04260397087664: Trial, H: 16 mm, 4°, 30/9
• 04260397084229: Trial, H: 16 mm, 18°, 30/9
• 04260397084205: Trial, H: 15 mm, 18°, 30/9
• 04260397084182: Trial, H: 14 mm, 18°, 30/9
• 04260397084168: Trial, H: 13 mm, 18°, 30/9
• 04260397084144: Trial, H: 12 mm, 18°, 30/9
• 04260397084106: Trial, H: 10 mm, 18°, 30/9
• 04260397084083: Trial, H: 15 mm, 12°, 30/9
• 04260397084069: Trial, H: 14 mm, 12°, 30/9
• 04260397084045: Trial, H: 13 mm, 12°, 30/9
• 04260397084021: Trial, H: 12 mm, 12°, 30/9