DB-600R DB-600R

GUDID 00816469020134

600u Reduced Buffer Laser Fiber

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00816469020134
• NIH Device Record Key: d50a894c-afac-4565-9935-58c8f99d363b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DB-600R
• Version Model Number: DB-600R
• Catalog Number: DB-600R
• Company DUNS: 177234754
• Company Name: LASER PERIPHERALS, LLC
• Device Count: 1
• DM Exempt: true
• 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: 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	00816469020134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030959

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by LASER PERIPHERALS, LLC

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• 00816469021629 - DBSS-272: 2022-05-30 272u Laser Fiber
• 00816469021636 - DBSS-272-PL: 2022-05-30 272u Laser Fiber PL
• 00816469021612 - DB-600R-5: 2021-11-29 600u Reduced Buffer Laser Fiber 5 use
• 00816469021599 - HTB-800: 2021-03-30 800u Laser Fiber
• 00816469021605 - HTB-800-PL: 2021-03-30 800u Laser Fiber PL
• 00816469021582 - DB-600R-HPT-PL: 2020-09-29 600u Reduced Buffer Laser Fiber w/ HPT PL