Laser Surgery Fibers and Probes LL11059s

GUDID 04260155591853

Otology probe short 300µm

A.R.C. Laser GmbH

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable
Primary Device ID04260155591853
NIH Device Record Keyd395c4b1-c747-4b20-afa4-61f1a15cbc0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Surgery Fibers and Probes
Version Model NumberLL11059s
Catalog NumberLL11059s
Company DUNS314885641
Company NameA.R.C. Laser GmbH
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260155591440 [Primary]
GS104260155591648 [Package]
Contains: 04260155591440
Package: [15 Units]
In Commercial Distribution
GS104260155591853 [Package]
Contains: 04260155591440
Package: [30 Units]
In Commercial Distribution
GS104260155592850 [Package]
Contains: 04260155591440
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


[04260155591853]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [Laser Surgery Fibers and Probes]

04260155591921Otology probe curved tip 20° universal centering
04260155591914Otology probe long universal centering
04260155591907Bare fiber 400 μm universal centering 1470 nm
04260155591891Bare fiber 600 μm/400 µm
04260155591884Bare fiber 400μm/300µm
04260155591877Endo probe 25 gauge
04260155591655Endo probe 20 gauge
04260155591853Otology probe short 300µm
04260155591846Otology probe long 300µm
04260155591426Flexible endo probe 23 gauge
04260155591730Bare Fiber 400µm
04260155591938Endoprobe 30° 23 gauge
4260155591822Endoprobe 30° 25 gauge
4260155591815Bare Fiber 600µm
4260155591808Bare Fiber 200µm
04260155591792Bare Fiber 300µm
04260155591785Bare Fiber 600µm universal centering
04260155591778Bare Fiber 300µm
04260155591761Endoprobe 21 gauge
04260155590443Endoprobe straight 20 gauge
04260155591747Endo Probe 23 Gauge
04260155592256HiFlex Fiber, 300 micrometer, Universal Centering
04260155592126HiFlex Fiber, 300 micrometer
04260155591983HiFlex Fiber, 400 micrometer, Universal Centering
04260155592287HiFlex Fiber, 400 micrometer
04260155592348HiFlex Fiber, 600 micrometers, Universal Centering

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