DC-1000B DC-1000B

GUDID 00816469020226

1000u Ball Tip Laser Fiber

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00816469020226
• NIH Device Record Key: 1c5767dc-475d-4c32-8d15-14121b2b9855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DC-1000B
• Version Model Number: DC-1000B
• Catalog Number: DC-1000B
• 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	00816469020226 [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

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• 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