DC-1000B DC-1000B

GUDID 00816469020226

1000u Ball Tip Laser Fiber

LASER PERIPHERALS, LLC

Urogenital surgical laser system beam guide, single-use
Primary Device ID00816469020226
NIH Device Record Key1c5767dc-475d-4c32-8d15-14121b2b9855
Commercial Distribution StatusIn Commercial Distribution
Brand NameDC-1000B
Version Model NumberDC-1000B
Catalog NumberDC-1000B
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
GS100816469020226 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by LASER PERIPHERALS, LLC

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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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