SCARLET AC-T INSTRUMENTATION SCA-IN 40 12-S

GUDID 07640151089085

Pins Ø 4.2 L12

SpineArt SA

Intraoperative bone pin/screw, sterile

• Primary Device ID: 07640151089085
• NIH Device Record Key: d777fae8-b706-4d9a-b13d-a77ce24d7e77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCARLET AC-T INSTRUMENTATION
• Version Model Number: SCA-IN 40 12-S
• Catalog Number: SCA-IN 40 12-S
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07640151089085 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-10
• Device Publish Date: 2016-09-27

On-Brand Devices [SCARLET AC-T INSTRUMENTATION]

• 07640178982239: TRIAL LARGE - LORDOTIC
• 07640178982222: TRIAL LARGE - LORDOTIC
• 07640178982215: TRIAL LARGE - LORDOTIC
• 07640178982208: TRIAL SMALL - LORDOTIC
• 07640178982192: TRIAL SMALL - LORDOTIC
• 07640178982185: TRIAL SMALL - LORDOTIC
• 07640178982178: TRIAL LARGE
• 07640178982161: TRIAL LARGE
• 07640178982154: TRIAL LARGE
• 07640178982147: TRIAL SMALL
• 07640178982130: TRIAL SMALL
• 07640178982123: TRIAL SMALL
• 07640178982116: RASP TRIAL LARGE
• 07640178982109: RASP TRIAL LARGE
• 07640178982093: RASP TRIAL LARGE
• 07640178982086: RASP TRIAL SMALL
• 07640178982079: RASP TRIAL SMALL
• 07640178982062: RASP TRIAL SMALL
• 07640178980099: Pins Ø 4.2 L10
• 07640178975729: LOW-PROFILE IMPLANT HOLDER
• 07640178975712: LOW-PROFILE IMPLANT HOLDER
• 07640178975705: LOW-PROFILE IMPLANT HOLDER
• 07640178975699: LOW-PROFILE IMPLANT HOLDER
• 07640178975682: LOW-PROFILE IMPLANT HOLDER
• 07640178975675: LOW-PROFILE IMPLANT HOLDER
• 07640178975668: LOW-PROFILE IMPLANT HOLDER
• 07640178975651: LOW-PROFILE IMPLANT HOLDER
• 07640178975644: LOW-PROFILE IMPLANT HOLDER
• 07640178975637: LOW-PROFILE IMPLANT HOLDER
• 07640178975620: LOW-PROFILE IMPLANT HOLDER
• 07640178975613: LOW-PROFILE IMPLANT HOLDER
• 07640178975606: ANGLED CUTTING SQUARE AWL
• 07640178975590: STRAIGHT CUTTING SQUARE AWL
• 07640178973817: LOCKING KNOB
• 07640178972810: DISPOSABLE STRAIGHT DRILL
• 07640178972292: Trial H09 - H10 Large - Lordotic
• 07640178972285: Trial H07 - H08 Large - Lordotic
• 07640178972278: Trial H05 - H06 Large - Lordotic
• 07640178972261: Trial H09 - H10 Small - Lordotic
• 07640178972254: Trial H07 - H08 Small - Lordotic
• 07640178972247: Trial H05 - H06 Small - Lordotic
• 07640178972230: Rasp Trial H09 - H10 Large - Lordotic
• 07640178972223: Rasp Trial H07 - H08 Large - Lordotic
• 07640178972216: Rasp Trial H05 - H06 Large - Lordotic
• 07640178972209: Rasp Trial H09 - H10 Small - Lordotic
• 07640178972193: Rasp Trial H07 - H08 Small - Lordotic
• 07640178972186: Rasp Trial H05 - H06 Small - Lordotic
• 07640178971516: DISTRACTOR PARALLEL INTERSOMATIC ENDTIP
• 07640151110093: Pins Ø 4.2 L10
• 07640151092290: Trial H09 - H10 Large - Lordotic