RB-365 RB-365

GUDID 00816469020660

365u Reusable Laser Fiber

LASER PERIPHERALS, LLC

General/multiple surgical laser system beam guide, reusable
Primary Device ID00816469020660
NIH Device Record Keycdfb0156-5c58-45e2-a8ff-fd50499ee84b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRB-365
Version Model NumberRB-365
Catalog NumberRB-365
Company DUNS177234754
Company NameLASER PERIPHERALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100816469020660 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by LASER PERIPHERALS, LLC

00816469021674 - LG-200-CN2024-12-16 LaseGuide® Connect 200u Laser Fiber
00816469021681 - LG-200-CN-PL2024-12-16 LaseGuide® Connect 200u Laser Fiber PL
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

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