SACRLET AC-T INSTRUMENTATION SCA-IC 1S 05-N

GUDID 07640151086602

Trials Small H05-06

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640151086602
• NIH Device Record Key: 8fd0396c-741f-4da5-8096-c5f33ee51789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SACRLET AC-T INSTRUMENTATION
• Version Model Number: SCA-IC 1S 05-N
• Catalog Number: SCA-IC 1S 05-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	07640151086602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141314

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

[07640151086602]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-27

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• 07640178984202 - ROMEO Posterior Osteosynthesis system: 2025-03-17 Open Iliac connector L15
• 07640178984219 - ROMEO Posterior Osteosynthesis system: 2025-03-17 Open Iliac connector L20
• 07640178984226 - ROMEO Posterior Osteosynthesis system: 2025-03-17 Open Iliac connector L30
• 07640178984233 - ROMEO Posterior Osteosynthesis system: 2025-03-17 Open Iliac connector L40
• 07640178984240 - ROMEO Posterior Osteosynthesis system: 2025-03-17 Open Iliac connector L50