8013064 8013064

GUDID 00816469021278

600u Reduced Buffer Fiber Unstripped PL

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use
Primary Device ID00816469021278
NIH Device Record Key94eeec2a-616e-4fed-ba0e-ce3f6a4d1aa1
Commercial Distribution StatusIn Commercial Distribution
Brand Name8013064
Version Model Number8013064
Catalog Number8013064
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
GS100816469021278 [Primary]

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 Date2019-10-16
Device Publish Date2019-10-08

Devices Manufactured by LASER PERIPHERALS, LLC

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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-PL2021-03-30 800u Laser Fiber PL
00816469021582 - DB-600R-HPT-PL2020-09-29 600u Reduced Buffer Laser Fiber w/ HPT PL

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