JULIET TL Instruments DYN-IT 01 01-N

GUDID 07640450863294

IMPLANT HOLDER SHAFT (JULIET ® TL)

SpineArt SA

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: 07640450863294
• NIH Device Record Key: ae9117fe-4025-4c5b-9f31-6c35f5307b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JULIET TL Instruments
• Version Model Number: DYN-IT 01 01-N
• Catalog Number: DYN-IT 01 01-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	07640450863294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081888

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

[07640450863294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-01
• Device Publish Date: 2021-03-24

On-Brand Devices [JULIET TL Instruments]

• 07640450863317: IMPLANT HOLDER HANDLE (JULIET ® TL)
• 07640450863300: IMPLANT HOLDER TUBE (JULIET ® TL)
• 07640450863294: IMPLANT HOLDER SHAFT (JULIET ® TL)
• 07640178989092: INSTRUMENT BOX