BAGUERA C INSTRUMENTATION CDP-IN 50 02-N

GUDID 07640178983687

ARTICULATED CERVICAL DISTRACTOR LEFT

SpineArt SA

Orthopaedic surgical distractor, internal

• Primary Device ID: 07640178983687
• NIH Device Record Key: 09a42ba7-0623-4495-be23-cf699e2843e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BAGUERA C INSTRUMENTATION
• Version Model Number: CDP-IN 50 02-N
• Catalog Number: CDP-IN 50 02-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	07640178983687 [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

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

[07640178983687]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-11
• Device Publish Date: 2019-04-03

On-Brand Devices [BAGUERA C INSTRUMENTATION]

• 07640139343727: Articulated Cervical distractor
• 07640139343192: Nut for Pins
• 07640139343178: Pins Ø 4.2 L18
• 07640139343161: Pins Ø 4.2 L16
• 07640139343154: Pins Ø 4.2 L14
• 07640139343147: Pins Ø 4.2 L12
• 07640139343130: Pins Ø 3.6 L16
• 07640139343123: Pins Ø 3.6 L16
• 07640139343116: Pins Ø 3.6 L14
• 07640139343109: Pins Ø 3.6 L12
• 07640178983687: ARTICULATED CERVICAL DISTRACTOR LEFT
• 07640178971189: ADJUSTABLE STOP NUT
• 07640178971172: ADJUSTABLE STOP NUT
• 07640305160202: ADJUSTABLE STOP
• 07640139343086: DISTRACTION FORCEPS
• 07640139343055: IMPLANT HOLDER