HTB-800-PL HTB-800-PL

GUDID 00816469021605

800u Laser Fiber PL

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00816469021605
• NIH Device Record Key: 57085dbd-e330-4fe4-b8fb-d8f8b7d03cf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTB-800-PL
• Version Model Number: HTB-800-PL
• Catalog Number: HTB-800-PL
• 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	00816469021605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170366

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-30
• Device Publish Date: 2021-03-22

Devices Manufactured by LASER PERIPHERALS, LLC

• 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: 2021-03-30800u Laser Fiber PL
• 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
• 00816469021537 - LG-272-N-PL-M: 2020-08-18 LaseGuide® Nav 272u Laser Fiber PL
• 00816469021544 - LG-365-E-PL-M: 2020-08-18 LaseGuide® Edge 365u Laser Fiber PL