Soltive

GUDID 00821925044586

TFL PREMIUM LASER UNIT - COMPONENT PART

Gyrus Acmi, Inc.

General/multiple surgical solid-state laser system

• Primary Device ID: 00821925044586
• NIH Device Record Key: af22f3df-3344-43dd-bf7a-dfa82c218dbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soltive
• Version Model Number: TFL-CPLU
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925044586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183647
• Premarket Notification: K242191

FDA Product Code

• GEX: Powered laser surgical instrument

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: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [Soltive]

• 00821925044586: TFL PREMIUM LASER UNIT - COMPONENT PART
• 00821925044616: TFL LASER INTERLOCK CONNECTOR
• 00821925044609: TFL LASER VIDEO CABLE ADAPTER
• 00821925044593: TTFL STANDARD LASER UNIT - COMPONENT PART
• 00821925044500: TFL LASER VIDEO CABLE
• 00821925044487: TFL LASER EU STANDARD POWER CORD
• 00821925044463: TFL LASER US STANDARD POWER CORD
• 00821925044449: TFL FIBER STRIPPER, 940 MICRON, AUTOCLAVABLE
• 00821925044425: TFL FIBER STRIPPER, 550 MICRON, AUTOCLAVABLE
• 00821925044401: TFL FIBER STRIPPER, 365 MICRON, AUTOCLAVABLE
• 00821925044388: TFL FIBER STRIPPER, 200 MICRON, AUTOCLAVABLE
• 00821925044340: TFL FIBER CLEAVER
• 00821925044326: TFL LASER BLAST SHIELD
• 00821925044302: TFL LASER WARNING SIGN
• 00821925044272: TFL Laser Footswitch - Wireless
• 00821925044258: TFL Laser Footswitch - Wired
• 00821925044135: TFL STANDARD LASER SYSTEM
• 00821925044111: TFL PREMIUM LASER SYSTEM
• 00821925044036: 550 Micron TFL Single Use Fiber, 5/Box
• 00821925044098: SOLTIVE SUPERPULSED LASER FIBER (5/Pk)
• 00821925043879: SOLTIVE SuperPulsed Laser Fiber 150 Micron
• 00821925044074: SOLTIVE SuperPulsed Laser Fiber 940 Micron
• 00821925043992: SOLTIVE SuperPulsed Laser Fiber 365 Micron
• 00821925043978: SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043930: SOLTIVE SuperPulsed Laser Fiber 200 Micron
• 00821925043916: SOLTIVE SuperPulsed Laser Fiber 150 Micron