Scarlet AL-T Instruments SPE-US S0 12-N

GUDID 07640185348516

SMOOTH TRIAL Small

SpineArt SA

Spinal implant trial

• Primary Device ID: 07640185348516
• NIH Device Record Key: 70c1fb38-1e7f-406d-a557-fc002dcb1230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scarlet AL-T Instruments
• Version Model Number: SPE-US S0 12-N
• Catalog Number: SPE-US S0 12-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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree
• Height: 12 Millimeter
• Angle: 10 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640185348516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181818

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [Scarlet AL-T Instruments]

• 07640185348578: SMOOTH TRIAL Small
• 07640185348561: SMOOTH TRIAL Small
• 07640185348554: SMOOTH TRIAL Small
• 07640185348547: SMOOTH TRIAL Small
• 07640185348530: SMOOTH TRIAL Small
• 07640185348523: SMOOTH TRIAL Small
• 07640185348516: SMOOTH TRIAL Small
• 07640185348509: SMOOTH TRIAL Small
• 07640185348493: SMOOTH TRIAL Medium
• 07640185348486: SMOOTH TRIAL Medium
• 07640185348479: SMOOTH TRIAL Medium
• 07640185348462: SMOOTH TRIAL Medium
• 07640185348455: SMOOTH TRIAL Medium
• 07640185348448: SMOOTH TRIAL Medium
• 07640185348431: SMOOTH TRIAL Medium
• 07640185348424: SMOOTH TRIAL Large
• 07640185348417: SMOOTH TRIAL Large
• 07640185348400: SMOOTH TRIAL Large
• 07640185348394: SMOOTH TRIAL Large
• 07640185348387: SMOOTH TRIAL Large
• 07640185348370: SMOOTH TRIAL Large
• 07640185348363: SMOOTH TRIAL Large
• 07640185348356: SMOOTH TRIAL Large