JAZZ Lock 560327

GUDID 10889981188436

IMPLANET

Internal spinal fixation system cable tensioner

• Primary Device ID: 10889981188436
• NIH Device Record Key: a9836eba-2e58-44eb-834f-2c0ec44fc16c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JAZZ Lock
• Version Model Number: JAZZ Lock Tensioner Stem
• Catalog Number: 560327
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981188436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153348

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

Sterilization

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

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

[10889981188436]

Moist Heat or Steam Sterilization

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