CoolLipoTM M220921N

GUDID 04059497000358

LEONI Fiber Optics GmbH

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 04059497000358
• NIH Device Record Key: 5acc86f3-8ca4-48f6-a54f-0e39ab2cd384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoolLipoTM
• Version Model Number: CL 320 R
• Catalog Number: M220921N
• Company DUNS: 342703174
• Company Name: LEONI Fiber Optics GmbH
• 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: 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	04059497000112 [Primary]
GS1	04059497000358 [Package]; Contains: 04059497000112; Package: [5 Units]; In Commercial Distribution
GS1	04059497000594 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050738

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

[04059497000358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [CoolLipoTM]

• 04059497000747: CL 500 S
• 04059497000358: CL 320 R
• 04059497000587: CL 500 R
• 04059497000273: CL 320 S