JAZZ Lock 360700

GUDID 10889981188146

IMPLANET

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 10889981188146
• NIH Device Record Key: 3c961a17-7f16-42d1-b591-eab27ba001e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAZZ Lock
• Version Model Number: JAZZ LOCK
• Catalog Number: 360700
• Company DUNS: 291993439
• Company Name: IMPLANET
• 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: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981188146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153348

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [JAZZ Lock]

• 10889981188436: JAZZ Lock Tensioner Stem
• 10889981188429: Crimper
• 10889981188146: JAZZ LOCK
• 03607505503325: JAZZ LOCK- Sterilization tray - Basis
• 03607505503318: JAZZ LOCK- Sterilization tray - Lid