Opus Colibri 0.7mm Single-use Tip Set (X6) AACL03052004

GUDID 17290110122154

Opus Colibri 0.7mm Single-use Tip Set of 6 units

ALMA LASERS LTD.

Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system Radio-frequency skin contouring system

• Primary Device ID: 17290110122154
• NIH Device Record Key: ed89d99e-3fea-4391-ab03-2b8dd582367c
• Commercial Distribution Discontinuation: 2021-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Opus Colibri 0.7mm Single-use Tip Set (X6)
• Version Model Number: 1
• Catalog Number: AACL03052004
• Company DUNS: 532283264
• Company Name: ALMA LASERS LTD.
• 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: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110122154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101147

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-22
• Device Publish Date: 2021-11-14

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