JULIET® Ti LL SPE-US 00 92-N

GUDID 07640450866196

Windowed Cage and Plate Holder

SpineArt SA

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 07640450866196
• NIH Device Record Key: 89d93ee7-e13e-4aaf-8999-5adfa11eb220
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JULIET® Ti LL
• Version Model Number: SPE-US 00 92-N
• Catalog Number: SPE-US 00 92-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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	07640450866196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190877

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

[07640450866196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-10
• Device Publish Date: 2021-09-02

On-Brand Devices [JULIET® Ti LL]

• 07640450863324: SPLIT TIP T15 UNIVERSAL JOINT DRIVER
• 07640450866196: Windowed Cage and Plate Holder