PERLA CPF-AC 3C 5O-S

GUDID 07640178977679

AXIAL CONNECTOR 3C-5O

SpineArt SA

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 07640178977679
• NIH Device Record Key: 0adec404-d1b3-4e2d-a31b-15a1ab429e97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERLA
• Version Model Number: CPF-AC 3C 5O-S
• Catalog Number: CPF-AC 3C 5O-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	07640178977679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153386

FDA Product Code

• NKG: Orthosis, Cervical Pedicle Screw Spinal Fixation

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: 2019-02-21
• Device Publish Date: 2018-02-09

On-Brand Devices [PERLA]

• 07640178977679: AXIAL CONNECTOR 3C-5O
• 07640151097677: AXIAL CONNECTOR 3C-5O
• 07640375235787: PERLA LOCKING SCREWDRIVER