HTB-800-PL HTB-800-PL

GUDID 00816469021605

800u Laser Fiber PL

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use
Primary Device ID00816469021605
NIH Device Record Key57085dbd-e330-4fe4-b8fb-d8f8b7d03cf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTB-800-PL
Version Model NumberHTB-800-PL
Catalog NumberHTB-800-PL
Company DUNS177234754
Company NameLASER PERIPHERALS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816469021605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered laser surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-30
Device Publish Date2021-03-22

Devices Manufactured by LASER PERIPHERALS, LLC

00816469021650 - LG-T2002024-07-23 272/200um Tapered HP Laser Fiber
00816469021667 - LG-T200-PL2024-07-23 272/200um Tapered HP Laser Fiber PL
00816469021629 - DBSS-2722022-05-30 272u Laser Fiber
00816469021636 - DBSS-272-PL2022-05-30 272u Laser Fiber PL
00816469021612 - DB-600R-52021-11-29 600u Reduced Buffer Laser Fiber 5 use
00816469021599 - HTB-8002021-03-30 800u Laser Fiber
00816469021605 - HTB-800-PL2021-03-30800u Laser Fiber PL
00816469021605 - HTB-800-PL2021-03-30 800u Laser Fiber PL
00816469021582 - DB-600R-HPT-PL2020-09-29 600u Reduced Buffer Laser Fiber w/ HPT PL

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